Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Muscle mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Unicompartmental knee replacement (Procedure)
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.
Intervention: Total knee replacement (Procedure)
Outcomes
Primary Outcomes
Muscle mass
Time Frame: 2 years
Thigh muscle cross sectional area and radiological attenuation measured by CT
Secondary Outcomes
- Health related outcome measurement, questionnaire(2 years)
- Muscle function(2 years)
- Patient reported outcome measurement, knee function questionnaire (PROM).(2 years)
Investigators
Margareta Hedström
MD PhD
Karolinska Institutet