Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass

Study Overview
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Brief Summary
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Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement. 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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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. 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.

Official Title
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Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Unicompartmental knee replacement
* Procedure: Total knee replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medial gonarthritis, (Kellgren 3b-4) correctible varus deformity less than 10 degrees intact ACL proficient in written and spoken swedish Exclusion Criteria: Valgus gonarthritis 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UKA, unicompartmental knee replacement<br>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. | Procedure: Unicompartmental knee replacement<br>* Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis<br>* Other names: Oxford;|
| Experimental: TKA, total knee replacement<br>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. | Procedure: Total knee replacement<br>* Participants with a medial gonarthritis are operated with a total knee replacement<br>* Other names: PFC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Thigh muscle cross sectional area and radiological attenuation measured by CT | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds. | 2 years | 
| Health related outcome measurement, questionnaire | EQ5D, a qualitative measurement of patient perceived quality of life | 2 years | 
| Patient reported outcome measurement, knee function questionnaire (PROM). | Knee osteoarthritis outcome score (KOOS). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)