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

Knee Osteoarthritis Clinical Trial

— UKA or TKA?  

Official title:

Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02563756
• Other study ID #: UNITKAstudien2015
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2025

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: Margareta Hedström, MD, PhD
• Phone: +4670735959
• Email: margareta.hedstrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Unicompartmental knee replacement
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
• Total knee replacement
Participants with a medial gonarthritis are operated with a total knee replacement

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Thigh muscle cross sectional area and radiological attenuation measured by CT	2 years
Secondary	Muscle function	Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds.	2 years
Secondary	Health related outcome measurement, questionnaire	EQ5D, a qualitative measurement of patient perceived quality of life	2 years
Secondary	Patient reported outcome measurement, knee function questionnaire (PROM).	Knee osteoarthritis outcome score (KOOS).	2 years