Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-28 @ 7:20 AM
Study NCT ID:
NCT00733369
Status:
TERMINATED
Last Update Posted:
2016-09-13
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kdwyer2@its.jnj.com', 'title': 'Kimberly Dwyer, PhD, CCRA', 'organization': 'DePuy Ortho Joint US'}, 'certainAgreement': {'otherDetails': 'DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but the PI will retain final editorial control.In case of disagreement,DePuy and the PI will make every effort to meet in order to discuss and resolve any issues.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early.', 'description': "Study protocol was designed and executed on using 'knees' as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.", 'eventGroups': [{'id': 'EG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Joint crepitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Joint dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Allergy to metals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Pre-op to 1 Year Range of Motion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '13.11', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '10.71', 'spread': '14.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational \\&4 control) + 2 lost to follow up (1 Inv \\& 1 Contr) + 1 missing outcome (1 Inv \\& 0 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv \\& 4Contr)+1 Lost to follow up(1Inv \\& 0Contr)+2 Missing outcome(1Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational\\&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'This study has been terminated early, therefore the 5 year data was not collected.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '21.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv \\& 4Contr)+1 Lost to follow up(1Inv \\& 0Contr)+2 Missing outcome(1Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '22.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv \\& 4 Contr)+ 2 Lost to follow up (1 Inv \\& 1 Contr) + 1 Missing outcome (0 Inv \\& 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv \\& 4 Contr)+ 4 Revisions (1 Inv \\& 1 Contr)+ 3 Lost to follow up (2 Inv \\& 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'This study was terminated early due to a slow recruitment rate. 5 year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '43.7', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv \\& 4Contr)+1 Lost to follow up(1Inv \\& 0Contr)+2 Missing outcome(1Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '44.0', 'spread': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv \\& 4 Contr)+ 2 Lost to follow up (1 Inv \\& 1 Contr) + 1 Missing outcome (0 Inv \\& 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '42.5', 'spread': '23.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv \\& 4 Contr)+ 4 Revisions (1 Inv \\& 3 Contr) + 3 Lost to follow up (2 Inv \\& 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to a slow recruitment rate.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '24.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 1 Lost to follow up (1Inv \\& 0Contr) + 2 Missing outcome (1Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '25.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv \\& 4 Contr)+ 2 Lost to follow up (1 Inv \\& 1 Contr) + 3 Missing outcome (0 Inv \\& 3 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '25.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv \\& 4 Contr)+ 4 Revisions (1 Inv \\& 3 Contr) + 3 Lost to follow up (2 Inv \\& 1 Contr) + 1 Missing outcome (1 Inv \\& 0 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to slow recruitment rate, 5 year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '26.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv \\& 0Contr) + 2 Missing outcome (1Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '51.7', 'spread': '27.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv \\& 4 Contr)+ 2 Lost to follow up (1 Inv \\& 1 Contr) + 3 Missing outcome (0 Inv \\& 3 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '31.6', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '23.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv \\& 4 Contr) + 4 Revisions (1 Inv \\& 3 Contr) + 3 Lost to follow up (2 Inv \\& 1 Contr) + 1 Missing outcome (1 Inv \\& 0 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '15.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 1 Lost to follow up (1Inv \\& 0Contr) + 1 Missing outcome (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '19.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to a slow recruitment rate. 5 year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 1 Lost to follow up (1Inv \\& 0Contr) + 1 Missing outcome (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '19.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 1 Missing outcome (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '18.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 4 Revisions (1Inv \\& 3Contr) + 3 Lost to follow up (2Inv \\& 1Contr) + 1 Missing outcome (0Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to a slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 1 Lost to follow up (1Inv \\& 0Contr) + 1 Missing outcome (0Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.7', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-19.4', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 2 Missing outcome (1Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.3', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 4 Revisions (1Inv \\& 3Contr) + 3 Lost to follow up (2Inv \\& 1Contr) + 2 Missing outcome (0Inv \\& 2Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to a slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 1 Lost to follow up (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 1 Missing outcome (0Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 4 Revisions (1Inv \\& 3Contr) + 3 Lost to follow up (2Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early to slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 1 Lost to follow up (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 2 Lost to follow up (1 Inv \\& 1 Contr) + 1 Missing outcome ( 0 Inv \\& 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv \\& 4Contr) + 4 Revisions (1 Inv \\& 3 Contr) + 3 Lost to follow up (2 Inv \\& 1 Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 1 Lost to follow up (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 1 Missing outcome (0Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 4 Revisions (1Inv \\& 3Contr) + 3 Lost to follow up (2Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 1 Lost to follow up (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 1 Missing outcome (0Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 4 Revisions (1Inv \\& 3Contr) + 3 Lost to follow up (2Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to slow recruitment rate. 5 Year data not available.'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 1 Lost to follow up (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 1 Missing outcome (0Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + + 4 Revisions (1Inv \\& 3Contr) + 3 Lost to follow up (2Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '23.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 1 Lost to follow up (1Inv \\& 0Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '26.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 2 Lost to follow up (1Inv \\& 1Contr) + 3 Missing outcome (0Inv \\& 3Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '26.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': '106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv \\& 4 Contr) + 4 Revisions (4Inv \\& 4Contr)+ 3 Lost to follow up (2Inv \\& 1Contr)}'}, {'type': 'SECONDARY', 'title': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Number of Knees', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'OG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Knees', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Study terminated early due to slow recruitment rate. 5 Year data not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PFC Sigma RP-F', 'description': 'PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'FG001', 'title': 'PFC Sigma RP', 'description': 'PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '2 sites enrolled 106 knees in 98 subjects who were then randomized into 2 groups, 50 into the PFC Sigma RP-F group and 56 into the PFC Sigma RP group.', 'preAssignmentDetails': "Study protocol was designed and executed on using 'knees' as study units."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PFC Sigma RP-F', 'description': '125 patients to be allocated to this arm according to blinding envelopes\n\nPFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing'}, {'id': 'BG001', 'title': 'PFC Sigma RP', 'description': '125 patients to be allocated to this arm according to blinding envelopes\n\nPFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Study protocol was designed and executed on using 'knees' as study units. Out of 106 enrolled knees, 11 knees were removed from analysis for following reasons: 8 protocol violations \\[bilaterals accrued at site bilaterals not allowed; used 1st knee operated upon\\] (4 inv, 4 control); 2 ltfu (1 inv, 1 control); 1 missing outcome (1 inv, 0 control)."}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'whyStopped': 'This study was closed for the reason of slow recruitment with only 16% of the target subjects recruited over a 29 month period.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2008-08-12', 'resultsFirstSubmitDate': '2014-03-22', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-12', 'studyFirstPostDateStruct': {'date': '2008-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Pre-op to 1 Year Range of Motion.', 'timeFrame': '1 year', 'description': 'Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.'}], 'secondaryOutcomes': [{'measure': 'To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3-6 months', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.'}, {'measure': 'To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.'}, {'measure': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.'}, {'measure': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.'}, {'measure': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.'}, {'measure': 'To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.'}, {'measure': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '3 - 6 months', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '1 year', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '2 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}, {'measure': 'To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.', 'timeFrame': '5 years', 'description': 'EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroplasty', 'Replacement', 'Knee', 'PFC Sigma RPF', 'PFC Sigma RP'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA.\n\nThe secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.', 'detailedDescription': 'Primary Outcome: Change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F\n\nSecondary endpoints: Comparative evaluation of any post-operative variation between subjects receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects, aged between 45 and 75 years inclusive.\n* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.\n* Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.\n* Subjects who present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.\n* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet.\n* Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.\n* Female subjects who are pregnant or lactating.\n* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.\n* Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).\n* Subjects who are currently involved in any injury litigation claims.\n* Subjects with a known history of poor compliance to medical treatment.\n* Subjects who have previously had an osteotomy or significant surgery in the affected knee.'}, 'identificationModule': {'nctId': 'NCT00733369', 'briefTitle': 'A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy International'}, 'officialTitle': 'A Prospective, Single Blinded, Multi-centre Randomised Controlled Trial Comparing the Post Operative Range of Motion of the P.F.C. Sigma RP-F Knee With the P.F.C. Sigma RP Knee in Primary Total Knee Arthroplasty.', 'orgStudyIdInfo': {'id': 'CT 06/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PFC Sigma RP-F', 'description': '125 patients to be allocated to this arm according to blinding envelopes', 'interventionNames': ['Device: PFC Sigma RP-F']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PFC Sigma RP', 'description': '125 patients to be allocated to this arm according to blinding envelopes', 'interventionNames': ['Device: PFC Sigma RP']}], 'interventions': [{'name': 'PFC Sigma RP-F', 'type': 'DEVICE', 'description': 'An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing', 'armGroupLabels': ['PFC Sigma RP-F']}, {'name': 'PFC Sigma RP', 'type': 'DEVICE', 'description': 'An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing', 'armGroupLabels': ['PFC Sigma RP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Metropolitan Borough of Wirral', 'state': 'Mersyside', 'country': 'United Kingdom', 'facility': 'Arrowe Park Hospital', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}