Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-30 @ 8:58 AM
Study NCT ID:
NCT00967161
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2009-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2009-08-26', 'studyFirstSubmitQcDate': '2009-08-26', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The motion analysis assessments of the knee', 'timeFrame': 'pre-op,6,12 months following surgery'}], 'secondaryOutcomes': [{'measure': 'Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.', 'timeFrame': 'pre-op,6,12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['knee replacement motion analysis'], 'conditions': ['Arthropathy of Knee Joint']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to analyze and compare the lower-limb joint motions and muscle activation patterns during activities of daily living as well as self reported health related functional outcomes for patients with osteoarthritis of the knee undergoing one of two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).', 'detailedDescription': 'Inclusion:\n\n40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.\n\nPatients who do not meet any exclusion criteria.\n\nExclusion:\n\nPotential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.\n\nExclusion for patient group\n\n1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.\n2. Patients with any other joint replacement in the ipsilateral and contralateral limb.\n3. Patients with evidence of active infection.\n4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.\n5. Patients with neuropathic joints.\n6. Patients requiring structural bone grafts.\n7. Patients with a documented allergy to cobalt chromium molybdenum.\n8. Patient with a BMI larger than 30 kg/m2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.Patients who do not meet any exclusion criteria.\n\nExclusion Criteria:\n\n* Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.\n\nExclusion for patient group\n\n1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.\n2. Patients with any other joint replacement in the ipsilateral and contralateral limb.\n3. Patients with evidence of active infection.\n4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.\n5. Patients with neuropathic joints.\n6. Patients requiring structural bone grafts.\n7. Patients with a documented allergy to cobalt chromium molybdenum.\n8. Patient with a BMI larger than 30 kg/m2.'}, 'identificationModule': {'nctId': 'NCT00967161', 'briefTitle': 'Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': '3D Motion Analysis of Evolution Medial Pivot Knee VS Posterior Stabilized Knee Arthroplasty for Osteoarthritis of the Knee.Feasibility Pilot for a Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'OHREB 2009-240-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evolution Medial Pivot Knee', 'description': '20 Patients will receive the EMP Knee Implant', 'interventionNames': ['Procedure: Total Knee Arthroplasty', 'Procedure: Motion analysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon PS Knee', 'description': '20 Patients will receive the Triathlon PS Knee', 'interventionNames': ['Procedure: Total Knee Arthroplasty', 'Procedure: Motion analysis']}], 'interventions': [{'name': 'Total Knee Arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['non applicable'], 'description': 'Total Knee Arthroplasty', 'armGroupLabels': ['Evolution Medial Pivot Knee', 'Triathlon PS Knee']}, {'name': 'Motion analysis', 'type': 'PROCEDURE', 'otherNames': ['non applicable'], 'description': 'Motion analysis (Gait/EMG during walking and functional tasks)', 'armGroupLabels': ['Evolution Medial Pivot Knee', 'Triathlon PS Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'k1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa General Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Geoffrey Dervin, MD,MSc,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHRI / The Ottawa Hospital/ University of Ottawa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}