Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-24 @ 12:34 AM
Study NCT ID:
NCT02563756
Status:
UNKNOWN
Last Update Posted:
2020-10-26
First Post:
2015-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle mass', 'timeFrame': '2 years', 'description': 'Thigh muscle cross sectional area and radiological attenuation measured by CT'}], 'secondaryOutcomes': [{'measure': 'Muscle function', 'timeFrame': '2 years', 'description': 'Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds.'}, {'measure': 'Health related outcome measurement, questionnaire', 'timeFrame': '2 years', 'description': 'EQ5D, a qualitative measurement of patient perceived quality of life'}, {'measure': 'Patient reported outcome measurement, knee function questionnaire (PROM).', 'timeFrame': '2 years', 'description': 'Knee osteoarthritis outcome score (KOOS).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medial gonarthritis, knee osteoarthritis,', 'Muscle function, muscle mass, muscle atrophy', 'Total knee arthroplasty (TKA)', 'Unicondylar knee arthroplasty (UKA)', 'Total knee replacement (TKR)', 'Unicondylar knee replacement (UKR)', 'Health-related quality of life (HRQoL)', 'Patient related outcome measurements (PROMs)'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement.\n\nPrimary outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT Secondary aims: functional tests, gait analysis, health related quality of life and patient related outcome.', 'detailedDescription': 'Objective: The investigators aim with the present study was to compare patient related outcome measurements, knee function and muscle mass in patients operated with an UKR or a TKR for medial gonarthritis.\n\nHypothesis: The investigators hypothesize that a greater number of patients might benefit from a less invasive surgery in terms of increased quality of life, function and muscle mass.\n\nPrimary Outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT.\n\nSecondary outcomes: Functional tests (timed up and go, 30s sit and stand, forward reach, forward step down, 6 min walk and 40 m walk test), knee strength (Biodex isokinetic dynamometer) and patient reported pain on a visual analogue scale (VAS). A number of PROMs: Health related quality of life (EQ-5D), Knee injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS) and Forgotten Joint Score (FJS) as well as 3D movement and gait analysis.\n\nInclusion criteria: Unilateral medial osteoarthritis of the knee (Kellgren 3b-4), aged 50 or above.\n\nExclusion criteria: Insufficient anterior cruciate ligament (ACL). Fixed varus deformity \\>10°, fixed flexion deformity \\>10°, flexion \\<100°. Previous high tibial osteotomy on the same side. Any neurological disease affecting strength or locomotion in any leg. Body mass index (BMI) \\>35. Rheumatoid disease. Symptomatic osteoarthritis of the contra lateral knee or any hip. Insufficient written or spoken Swedish.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medial gonarthritis, (Kellgren 3b-4)\n* correctible varus deformity less than 10 degrees\n* intact ACL\n* proficient in written and spoken swedish\n\nExclusion Criteria:\n\n* Valgus gonarthritis\n* flexion deformity of 10 degrees\n* knee flexion of less than 100 degrees\n* previous high tibial osteotomy\n* neuromuscular disorders of lower extremities\n* symptomatic osteoarthritis of the contralateral knee or any hip.'}, 'identificationModule': {'nctId': 'NCT02563756', 'acronym': 'UKA or TKA?', 'briefTitle': 'Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass', 'orgStudyIdInfo': {'id': 'UNITKAstudien2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UKA, unicompartmental knee replacement', 'description': 'Procedure: Participants are operated with a mobile bearing medial unicompartmental knee arthroplasty (Oxford). They are followed with CT, functional tests and PROM, compared with those operated with TKA.', 'interventionNames': ['Procedure: Unicompartmental knee replacement']}, {'type': 'EXPERIMENTAL', 'label': 'TKA, total knee replacement', 'description': 'Procedure: Participants are operated with a cruciate retaining conventional tricompartmental prosthesis (PFC). They are followed with CT, functional tests and PROM, compared with those operated with UKA.', 'interventionNames': ['Procedure: Total knee replacement']}], 'interventions': [{'name': 'Unicompartmental knee replacement', 'type': 'PROCEDURE', 'otherNames': ['Oxford'], 'description': 'Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis', 'armGroupLabels': ['UKA, unicompartmental knee replacement']}, {'name': 'Total knee replacement', 'type': 'PROCEDURE', 'otherNames': ['PFC'], 'description': 'Participants with a medial gonarthritis are operated with a total knee replacement', 'armGroupLabels': ['TKA, total knee replacement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Carl Aulin, MD', 'role': 'CONTACT', 'email': 'carl.aulin@karolinska.se'}, {'name': 'Nicolas Martinez, MD', 'role': 'CONTACT', 'email': 'nicolas.martinez-carranza@karolinska.se', 'phone': '+46709900089'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Margareta Hedström, MD, PhD', 'role': 'CONTACT', 'email': 'margareta.hedstrom@ki.se', 'phone': '+4670735959'}, {'name': 'Nicolas Martinez, MD', 'role': 'CONTACT', 'phone': '+46709900089'}], 'overallOfficials': [{'name': 'Margareta Hedström, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CLINTEC, Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Margareta Hedström', 'investigatorAffiliation': 'Karolinska Institutet'}}}}