Clinical trial NCT02563756: Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass
Official title: Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Medial gonarthritis, knee osteoarthritis,
Muscle function, muscle mass, muscle atrophy
Total knee arthroplasty (TKA)
Unicondylar knee arthroplasty (UKA)
Total knee replacement (TKR)
Unicondylar knee replacement (UKR)
Health-related quality of life (HRQoL)
Patient related outcome measurements (PROMs)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle mass
timeFrame: 2 years
Secondary outcomes:
measure: Muscle function
timeFrame: 2 years
measure: Health related outcome measurement, questionnaire
timeFrame: 2 years
measure: Patient reported outcome measurement, knee function questionnaire (PROM).
timeFrame: 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: CLINTEC, Karolinska Institutet
name: Margareta Hedström, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: