Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT00375856
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2006-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2006-09-12', 'studyFirstSubmitQcDate': '2006-09-12', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait and radiographic parameters', 'timeFrame': '0'}], 'secondaryOutcomes': [{'measure': 'Knee pain, function', 'timeFrame': '0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arthroplasty', 'knee', 'computer-assist', 'gait', 'Total knee arthroplasty', 'knee prostheses'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Primary Research Questions:\n\n1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (TKA) using the Sigma fixed bearing knee?\n2. Do patients with knee OA who undergo TKA with a Sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo TKA using the Sigma fixed bearing knee?\n3. Do patients with knee OA who undergo TKA with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)?\n4. Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-75 years\n* Undergoing primary total knee arthroplasty\n* Clinically significant osteoarthritic degeneration\n\nExclusion Criteria:\n\n* Active articular infections\n* Bilateral knee replacement (simultaneous)\n* Previous joint infections\n* Significant concurrent ipsilateral hip osteoarthritis\n* Chronic pain syndrome requiring medications for control\n* History of chemical addiction\n* Significant spinal stenosis, significant symptomatic sciatica\n* Patients who are unlikely to comply with, participate in, or return for follow-up visits as described in the protocol\n* Osteomyelitis, septicemia or other infections that may spread to other areas of the body\n* Highly communicable diseases, immuno-compromising conditions and/or conditions that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)\n* Decreased mental comprehension and literacy\n* Prior high tibial osteotomy\n* Prior patellectomy\n* Rheumatoid arthritis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00375856', 'briefTitle': 'Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems', 'orgStudyIdInfo': {'id': 'DepuyRP06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Rotating Platform Knee', 'interventionNames': ['Device: DePuy P.F.C.® Sigma Rotating Platform Knee']}], 'interventions': [{'name': 'DePuy P.F.C.® Sigma Rotating Platform Knee', 'type': 'DEVICE', 'otherNames': ['no other name'], 'description': 'no details', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2K 3S8', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'John F Rudan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University/Kingston General Hospital"}, {'name': 'Steve MacDonald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Center'}, {'name': 'Eric Bohm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba/Concordia Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. John Rudan', 'investigatorAffiliation': "Queen's University"}}}}