Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02563756
Brief Summary:
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:
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:
NCT02563756
Study Brief:
Protocol Section:
NCT02563756