Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass
NCT ID: NCT02563756
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2015-09-30
2025-09-30
Brief Summary
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Primary 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.
Detailed Description
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Hypothesis: 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.
Primary Outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT.
Secondary 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.
Inclusion criteria: Unilateral medial osteoarthritis of the knee (Kellgren 3b-4), aged 50 or above.
Exclusion 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UKA, unicompartmental knee replacement
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.
Unicompartmental knee replacement
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
TKA, total knee replacement
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.
Total knee replacement
Participants with a medial gonarthritis are operated with a total knee replacement
Interventions
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Unicompartmental knee replacement
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
Total knee replacement
Participants with a medial gonarthritis are operated with a total knee replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* correctible varus deformity less than 10 degrees
* intact ACL
* proficient in written and spoken swedish
Exclusion Criteria
* flexion deformity of 10 degrees
* knee flexion of less than 100 degrees
* previous high tibial osteotomy
* neuromuscular disorders of lower extremities
* symptomatic osteoarthritis of the contralateral knee or any hip.
50 Years
100 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Margareta Hedström
MD PhD
Principal Investigators
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Margareta Hedström, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
CLINTEC, Karolinska Institutet
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Nicolas Martinez, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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UNITKAstudien2015
Identifier Type: -
Identifier Source: org_study_id