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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Unicompartmental knee replacement; Procedure: Total knee replacement

• Registration Number: NCT02563756
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26
• Primary Completion: 2022-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• medial gonarthritis, (Kellgren 3b-4)
• correctible varus deformity less than 10 degrees
• intact ACL
• proficient in written and spoken swedish

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UKA, unicompartmental knee replacement	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.
TKA, total knee replacement	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.

Primary Outcome Measures

Name	Time	Method
Muscle mass	2 years	Thigh muscle cross sectional area and radiological attenuation measured by CT

Secondary Outcome Measures

Name	Time	Method
Health related outcome measurement, questionnaire	2 years	EQ5D, a qualitative measurement of patient perceived quality of life
Muscle function	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.
Patient reported outcome measurement, knee function questionnaire (PROM).	2 years	Knee osteoarthritis outcome score (KOOS).

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden