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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|