Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-25 @ 3:02 AM
Study NCT ID:
NCT02157220
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual pain analogue score', 'timeFrame': '6 weeks', 'description': 'Participants asked to rate their level of pain on a scale'}, {'measure': 'Range of motion', 'timeFrame': '6 weeks', 'description': 'The range of motion of the joint was assessed in both flexion and extension'}, {'measure': 'Activities of Daily Living', 'timeFrame': '6 weeks', 'description': 'Questionnaire looking at how the intervention impacts of activities of daily living'}, {'measure': 'X-ray analysis of joint alignment', 'timeFrame': '5-7 year', 'description': 'Using X-rays, the knee was assessed for mechanical and anatomical alignment'}, {'measure': 'Visual pain analogue score', 'timeFrame': '6 months'}, {'measure': 'visual pain analogue score', 'timeFrame': '12 months'}, {'measure': 'visual analogue pain score', 'timeFrame': '5-7 years'}, {'measure': 'range of motion', 'timeFrame': '6 months'}, {'measure': 'range of motion', 'timeFrame': '1 year'}, {'measure': 'range of motion', 'timeFrame': '5-7 years'}, {'measure': 'activities of daily living', 'timeFrame': '6 months'}, {'measure': 'activities of daily living', 'timeFrame': '1 year'}, {'measure': 'activities of daily living', 'timeFrame': '5-7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This is a randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. Participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. The literature and joint registry of Australia shows that one of the prosthesis may be inferior to the other. Our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty\n\nExclusion Criteria:\n\n* refusal to participate\n* other simultaneous surgery\n* post traumatic osteoarthritis\n* prior open knee surgery'}, 'identificationModule': {'nctId': 'NCT02157220', 'briefTitle': 'Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'orgStudyIdInfo': {'id': 'HC12098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomised group 1', 'description': 'This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.', 'interventionNames': ['Device: Fixed bearing prosthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Randomised group 2', 'description': 'This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.', 'interventionNames': ['Device: Mobile bearing prosthesis']}], 'interventions': [{'name': 'Fixed bearing prosthesis', 'type': 'DEVICE', 'armGroupLabels': ['Randomised group 1']}, {'name': 'Mobile bearing prosthesis', 'type': 'DEVICE', 'armGroupLabels': ['Randomised group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2444', 'city': 'Port Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Dr Dean Pepper, orthopaedic surgeon private rooms', 'geoPoint': {'lat': -31.43084, 'lon': 152.90894}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Cameron Handford', 'investigatorFullName': 'Cameron Handford', 'investigatorAffiliation': 'The University of New South Wales'}}}}