Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-08 @ 12:16 AM
Study NCT ID:
NCT02429856
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ron.welch@ahs.ca', 'phone': '780-407-8007', 'title': 'Director of NACTRC', 'organization': 'UAlberta'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Revision of TKA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}, {'id': 'OG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}], 'classes': [{'categories': [{'measurements': [{'value': '84.0', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '24.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 years postoperative', 'description': 'disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'WOMAC Osteoarthritis Index Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants'}, {'id': 'OG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants'}], 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '72.7', 'spread': '23.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 years', 'description': 'disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'RAND -36 Health Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}, {'id': 'OG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '29.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 years postoperative', 'description': 'generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Revision Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}, {'id': 'OG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 10 years of surgery', 'description': 'number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}, {'id': 'OG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 10 years of surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These complications include the revisions already recorded.'}, {'type': 'SECONDARY', 'title': 'Knee Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}, {'id': 'OG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}], 'classes': [{'categories': [{'measurements': [{'value': '105.8', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '105.9', 'spread': '13.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'knee ROM at 2 years postoperative', 'description': 'Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants'}, {'id': 'FG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PCS Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants'}, {'id': 'BG001', 'title': 'PCR Group', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis\n\nSCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '69.2', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '69.7', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-23', 'studyFirstSubmitDate': '2015-04-17', 'resultsFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-10', 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain', 'timeFrame': '10 years postoperative', 'description': 'disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores'}, {'measure': 'WOMAC Osteoarthritis Index Function', 'timeFrame': '10 years', 'description': 'disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores'}], 'secondaryOutcomes': [{'measure': 'RAND -36 Health Survey', 'timeFrame': '10 years postoperative', 'description': 'generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function.'}, {'measure': 'Revision Rate', 'timeFrame': 'within 10 years of surgery', 'description': 'number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases'}, {'measure': 'Number of Complications', 'timeFrame': 'within 10 years of surgery'}, {'measure': 'Knee Range of Motion', 'timeFrame': 'knee ROM at 2 years postoperative', 'description': 'Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee', 'Knee Arthroplasty, Total']}, 'referencesModule': {'references': [{'pmid': '19047702', 'type': 'RESULT', 'citation': 'Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.', 'detailedDescription': 'RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA.\n\nSubjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for primary TKA\n* non-inflammatory arthritis\n* intact Posterior Cruciate Ligament at the time of surgery\n\nExclusion Criteria:\n\n* required bone grafting of either the femur or tibia\n* varus or valgus deformity of \\> 15 degrees\n* previous high tibial osteotomy\n* unable to understand or comply with the study requirements\n* unable to provide signed informed consent'}, 'identificationModule': {'nctId': 'NCT02429856', 'acronym': 'SCORPIO™', 'briefTitle': 'Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome', 'orgStudyIdInfo': {'id': 'Pro00002407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCS', 'description': 'SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis', 'interventionNames': ['Device: SCORPIO™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCR', 'description': 'SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis', 'interventionNames': ['Device: SCORPIO™']}], 'interventions': [{'name': 'SCORPIO™', 'type': 'DEVICE', 'description': 'subjects randomized at surgery to receive 1 of the 2 specified implants', 'armGroupLabels': ['PCR', 'PCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TG6 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services - Edmonton zone', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}