Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-31 @ 5:44 AM
Study NCT ID:
NCT00380861
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2006-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Implant Design Improve Postoperative Flexion?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TOdell2@its.jnj.com', 'phone': '574-372-7104', 'title': "Tammy O'Dell", 'organization': 'DePuy Orthopaedics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.', 'otherNumAtRisk': 93, 'otherNumAffected': 10, 'seriousNumAtRisk': 93, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.', 'otherNumAtRisk': 91, 'otherNumAffected': 8, 'seriousNumAtRisk': 91, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'seriousEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Polyethylene Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}, {'units': 'Knees', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Flexion for Standard Knee Device at Pre-op', 'description': 'Single leg passive flexion for Standard Knee Device at pre-op'}, {'id': 'OG001', 'title': 'Passive Flexion for Standard Knee Device at 6-months', 'description': 'Single leg passive flexion for Standard Knee Device at 6-months'}, {'id': 'OG002', 'title': 'Passive Flexion for Standard Knee Device at 12-months', 'description': 'Single leg passive flexion for Standard Knee Device at 12-months'}, {'id': 'OG003', 'title': 'Passive Flexion for High Flexion Knee Device at Pre-op', 'description': 'Single leg passive flexion High Flexion Knee Device at pre-op'}, {'id': 'OG004', 'title': 'Passive Flexion for High Flexion Knee Device at 6-months', 'description': 'Single leg passive flexion for High Flexion Knee Device at 6-months'}, {'id': 'OG005', 'title': 'Passive Flexion for High Flexion Knee Device at 12-months', 'description': 'Single leg passive flexion for High Flexion Knee Device at 12-months'}], 'classes': [{'categories': [{'measurements': [{'value': '111.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '118.9', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '120.2', 'spread': '11.3', 'groupId': 'OG002'}, {'value': '111.4', 'spread': '5.8', 'groupId': 'OG003'}, {'value': '120.9', 'spread': '12.7', 'groupId': 'OG004'}, {'value': '124.7', 'spread': '9.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months', 'description': 'The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.', 'unitOfMeasure': 'Degrees of passive flexion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees'}, {'type': 'SECONDARY', 'title': 'Patient Specific Anthropometrics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Thigh Circumference in Centimeters (cm)', 'description': 'Thigh circumference was measured 10 cm proximal to the superior aspect of the patella bone'}, {'id': 'OG001', 'title': 'Ankle Circumference in Centimeters (cm)', 'description': 'Ankle circumference was measured in centimeters'}, {'id': 'OG002', 'title': 'Skin-fold in Centimeters (cm)', 'description': 'Skin-fold was measured in the middle of the thigh, 10 cm proximal to the superior patellar pole, using calipers.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '3.23', 'spread': '1.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected at pre-op', 'description': 'Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'American Knee Society (AKS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKS for the Standard Knee Device', 'description': 'AKS for the Standard Knee Device at 12-months'}, {'id': 'OG001', 'title': 'AKS for the High Flexion Knee Device', 'description': 'AKS for the High Flexion Knee Device at 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '85.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '87.0', 'spread': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval', 'description': 'AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees'}, {'type': 'SECONDARY', 'title': 'KOOS Pain Sub-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}, {'units': 'Knees', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'KOOS Pain Sub-score Standard Knee Device at Pre-op', 'description': 'KOOS Pain Sub-score for Standard Knee Device at pre-op. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.'}, {'id': 'OG001', 'title': 'KOOS Pain Sub-score Standard Knee Device at 6-months', 'description': 'KOOS Pain Sub-score for Standard Knee Device at 6-months. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.'}, {'id': 'OG002', 'title': 'KOOS Pain Sub-score Standard Knee Device at 12-months', 'description': 'KOOS Pain Sub-score Standard Knee Device at 12-months. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.'}, {'id': 'OG003', 'title': 'KOOS Pain Sub-score High Flexion Knee Device at Pre-op', 'description': 'KOOS Pain Sub-score High Flexion Knee Device at pre-op. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems'}, {'id': 'OG004', 'title': 'KOOS Pain Sub-score High Flexion Knee Device at 6-months', 'description': 'KOOS Pain Sub-score High Flexion Device at 6-months. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.'}, {'id': 'OG005', 'title': 'KOOS Pain Sub-score High Flexion Knee Device at 12-months', 'description': 'KOOS Pain Sub-score High Flexion Knee Device at 12-months. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '84.0', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '89.5', 'spread': '14.0', 'groupId': 'OG002'}, {'value': '45.3', 'spread': '18.2', 'groupId': 'OG003'}, {'value': '83.1', 'spread': '14.9', 'groupId': 'OG004'}, {'value': '90.0', 'spread': '11.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up', 'description': "KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees'}, {'type': 'SECONDARY', 'title': 'Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}]}, {'units': 'Knees', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'KOOS Sub-scale for Activity of Daily Living (ADL) for Standard Knee Device at Pre-op', 'description': 'KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at pre-op. Scoring range is 0 (worst) to 100 (best)'}, {'id': 'OG001', 'title': 'KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at 6-months.', 'description': 'KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at 6-months. Scoring range is 0 (worst) to 100 (best)'}, {'id': 'OG002', 'title': 'KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at 12-months.', 'description': 'KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at 12-months. Scoring range is 0 (worst) to 100 (best)'}, {'id': 'OG003', 'title': 'KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at Pre-op', 'description': 'KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at pre-op. Score range is 0 (worst) to 100 (best)'}, {'id': 'OG004', 'title': 'KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at 6-months', 'description': 'KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at 6-monhts. Score range is 0 (worst) to 100 (best).'}, {'id': 'OG005', 'title': 'KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at 12-months', 'description': 'KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at 12-months. Score range is 0 (worst) to 100 (best).'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '90.4', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '47.9', 'spread': '19.2', 'groupId': 'OG003'}, {'value': '85.6', 'spread': '12.7', 'groupId': 'OG004'}, {'value': '90.1', 'spread': '11.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months', 'description': "KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.", 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees'}, {'type': 'SECONDARY', 'title': 'Patellar Crepitus Defined as No Crepitus, FINE or COARSE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}, {'units': 'Knees', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Crepitus in Standard (RP) Flexion Cohort at Pre-Op'}, {'id': 'OG001', 'title': 'Patellar Crepitus in High Flexion Cohort (RPF) at Pre-op'}, {'id': 'OG002', 'title': 'Patellar Crepitus in Standard Flexion (RP) Cohort at 6-months'}, {'id': 'OG003', 'title': 'Patellar Crepitus in High Flexion (RPF) Cohort at 6 Months'}, {'id': 'OG004', 'title': 'Patellar Crepitus in Standard Flexion (RP) Cohort at 12-months'}, {'id': 'OG005', 'title': 'Patellar Crepitus in High Flexion (RPF) Cohort at 12-months'}], 'classes': [{'categories': [{'title': 'NO Crepitus', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}, {'title': 'FINE Crepitus', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}, {'title': 'COARSE Crepitus', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Collected at Pre-operative, 6 weeks and 6 and 12 months', 'description': 'Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE.', 'unitOfMeasure': 'Knees', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'Patellar crepitus is measured by touch with the clinician placing a hand over the knee cap and moving the lower leg from flexion to extension. It is classified as coarse, fine or no crepitus.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Bilateral Patients Reporting Satisfaction at 12-months After Knee Replacement', 'description': 'All bilateral knee replacement patients participating in the Palm technology to assess satisfaction from pre-op goals to 12-months'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Collected pre-and post-op, reported at 12-months', 'description': 'Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Knee Society Passive Flexion at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.'}, {'id': 'OG001', 'title': 'PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.'}], 'classes': [{'categories': [{'measurements': [{'value': '124.2', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.', 'unitOfMeasure': 'Degrees of passive flexion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees'}, {'type': 'SECONDARY', 'title': 'Single Leg Active Flexion (SLAF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}, {'units': 'knees', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Leg Active Flexsion (SLAF) for the Standard Knee Device at Pre-op', 'description': 'Weight bearing Single Leg Active Flexion (SLAF) for the Standard Knee Device at pre-op'}, {'id': 'OG001', 'title': 'Single Leg Active Flexion (SLAF) for Standard Knee Device at 6-months', 'description': 'Weight bearing Single Leg Active Flexion (SLAF) for Standard Knee Device at 6-months'}, {'id': 'OG002', 'title': 'Single Leg Active Flexion (SLAF) for Standard Knee Device at 12-months', 'description': 'Weight bearing Single Leg Active Flexion (SLAF) for Standard Knee Device at 12-months'}, {'id': 'OG003', 'title': 'Single Leg Active Flexion (SLAF) High Flexion Knee Device at Pre-op', 'description': 'Weight bearing Single Leg Active Flexion (SLAF) for High Flexion Knee Device at pre-op'}, {'id': 'OG004', 'title': 'Single Leg Active Flexion (SLAF) for the High Flexion Knee Device at 6-months', 'description': 'Weight bearing Single Leg Active Flexion (SLAF) for High Flexion Knee Device at 6-months'}, {'id': 'OG005', 'title': 'Single Leg Active Flexion (SLAF) for the High Flexion Knee Device at 12-months', 'description': 'Weight bearing Single Leg Active Flexion (SLAF) for the High Flexion Knee Device at 12-months'}], 'classes': [{'categories': [{'measurements': [{'value': '124.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '126.0', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '126.6', 'spread': '10.6', 'groupId': 'OG002'}, {'value': '120.9', 'spread': '13.3', 'groupId': 'OG003'}, {'value': '125.2', 'spread': '10.8', 'groupId': 'OG004'}, {'value': '127.5', 'spread': '11.1', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-op, 6- and 12-months', 'description': 'Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain.', 'unitOfMeasure': 'Degrees of flexion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'knees', 'denomUnitsSelected': 'knees'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.'}, {'id': 'FG001', 'title': 'PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '93', 'numSubjects': '93'}, {'comment': 'Two subjects received the PFC Sigma RP-F device but not the RP and their results are not included.', 'groupId': 'FG001', 'numUnits': '91', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '75', 'numSubjects': '75'}, {'groupId': 'FG001', 'numUnits': '74', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '18'}, {'groupId': 'FG001', 'numUnits': '17', 'numSubjects': '17'}]}]}], 'typeUnitsAnalyzed': 'knees', 'recruitmentDetails': 'There were eight clinical investigators participating in the investigation. Subjects who were to receive simultaneous bilateral knee replacement were recruited for this study, where one knee was to receive the PFC Sigma Rotating Platform high flexion (RP-F) device and the other knee was to receive the PFC Sigma Rotating Platform (RP) device. 93 Subjects were enrolled in the study.', 'preAssignmentDetails': "The randomization was a two stage scheme in order to minimize bias that could potentially be introduced due to differences in preoperative range of motion (ROM) between a subject's right and left legs."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'units': 'knees', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.'}, {'id': 'BG001', 'title': 'PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement', 'description': 'Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Subjects have a Sigma RP in one knee and a Sigma RP-F in their other knee'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'knees', 'denomUnitsSelected': 'knees', 'populationDescription': 'there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'title': 'United States', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'knees', 'denomUnitsSelected': 'knees'}], 'typeUnitsAnalyzed': 'knees'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2006-09-26', 'resultsFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2006-09-26', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-07', 'studyFirstPostDateStruct': {'date': '2006-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Passive Flexion at 6 Months', 'timeFrame': '6 months', 'description': 'The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.'}], 'secondaryOutcomes': [{'measure': 'Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee', 'timeFrame': 'Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months', 'description': 'The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.'}, {'measure': 'Patient Specific Anthropometrics', 'timeFrame': 'Collected at pre-op', 'description': 'Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.'}, {'measure': 'American Knee Society (AKS) Score', 'timeFrame': 'Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval', 'description': 'AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition.'}, {'measure': 'KOOS Pain Sub-score', 'timeFrame': 'Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up', 'description': "KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems."}, {'measure': 'Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs', 'timeFrame': 'Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months', 'description': "KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems."}, {'measure': 'Patellar Crepitus Defined as No Crepitus, FINE or COARSE', 'timeFrame': 'Collected at Pre-operative, 6 weeks and 6 and 12 months', 'description': 'Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE.'}, {'measure': 'Subject Satisfaction', 'timeFrame': 'Collected pre-and post-op, reported at 12-months', 'description': 'Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients'}, {'measure': 'Single Leg Active Flexion (SLAF)', 'timeFrame': 'Pre-op, 6- and 12-months', 'description': 'Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Knee Replacement', 'Flexion', 'Range of Motion', 'Activities of Daily Living', 'Implant design', 'Subject Satisfaction', 'Non-inflammatory arthritis'], 'conditions': ['Non-inflammatory Arthritis']}, 'referencesModule': {'references': [{'pmid': '21123592', 'type': 'DERIVED', 'citation': "Tippett SR, Mang J, Dwyer KA, Lesko J, O'Dell T. Collecting data with Palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:59-67. doi: 10.2106/JBJS.J.00827. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.', 'detailedDescription': 'The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-Inflammatory Arthritis\n* Age = 40-70 years\n* Male or female\n* Suitable for devices in study\n* Needing primary simultaneous bilateral knee replacements\n* Willing to consent and authorize release of personal health information\n* Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,\n\nExclusion Criteria:\n\n* Existing conditions that would compromise participation\n* Multiple joint involvement\n* Pregnant/lactating women\n* Inflammatory arthritis\n* Fixed flexion contracture greater than 20 degrees\n* Previous knee replacement of any type\n* Needing device(s) not specified in protocol\n* The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up\n* Those who have participated in an investigation in the last 3 months\n* Those involved in personal injury litigation, medical-legal or workers compensation claims\n* Failure to follow surgical technique details specified in the protocol'}, 'identificationModule': {'nctId': 'NCT00380861', 'briefTitle': 'Does Implant Design Improve Postoperative Flexion?', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Orthopaedics'}, 'officialTitle': 'Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects', 'orgStudyIdInfo': {'id': '04092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PFC Sigma RP-F', 'description': 'PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.', 'interventionNames': ['Device: Total knee replacement using the PFC Sigma RPF knee implant.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PFC Sigma RP', 'description': 'P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement.', 'interventionNames': ['Device: Total knee replacement using the PFC Sigma RP knee implant']}], 'interventions': [{'name': 'Total knee replacement using the PFC Sigma RPF knee implant.', 'type': 'DEVICE', 'description': 'Total knee replacement', 'armGroupLabels': ['PFC Sigma RP-F']}, {'name': 'Total knee replacement using the PFC Sigma RP knee implant', 'type': 'DEVICE', 'description': 'Total knee replacement', 'armGroupLabels': ['PFC Sigma RP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Doug Dennis', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Heekin Orthopaedics', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '01075', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '98499', 'city': 'Lakewood', 'state': 'Washington', 'country': 'United States', 'facility': 'Lakewood Orthopaedic Surgeons', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}], 'overallOfficials': [{'name': "Tammy O'Dell, EMT, CCRA, CCRC", 'role': 'STUDY_DIRECTOR', 'affiliation': 'DePuy Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}