Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass (UKA or TKA?)
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|ClinicalTrials.gov Identifier: NCT02563756|
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : November 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Procedure: Unicompartmental knee replacement Procedure: Total knee replacement||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2022|
Experimental: 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.
Procedure: Unicompartmental knee replacement
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
Other Name: Oxford
Experimental: 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.
Procedure: Total knee replacement
Participants with a medial gonarthritis are operated with a total knee replacement
Other Name: PFC
- Muscle mass [ Time Frame: 2 years ]Thigh muscle cross sectional area and radiological attenuation measured by CT
- Muscle function [ Time Frame: 2 years ]Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds.
- Health related outcome measurement, questionnaire [ Time Frame: 2 years ]EQ5D, a qualitative measurement of patient perceived quality of life
- Patient reported outcome measurement, knee function questionnaire (PROM). [ Time Frame: 2 years ]Knee osteoarthritis outcome score (KOOS).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563756
|Contact: Margareta Hedström, MD, PhDfirstname.lastname@example.org|
|Contact: Nicolas Martinez, MD||+46709900089|
|Principal Investigator:||Margareta Hedström, MD,PhD||CLINTEC, Karolinska Institutet|