Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass (UKA or TKA?)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Unicompartmental knee replacement; Procedure: Total knee replacement

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margareta Hedström, MD, PhD; Phone Number: +4670735959; Email: margareta.hedstrom@ki.se
• Study Contact Backup: Name: Nicolas Martinez, MD; Phone Number: +46709900089

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Carl Aulin, MD; Email: carl.aulin@karolinska.se
    • Contact: Nicolas Martinez, MD; Phone Number: +46709900089; Email: nicolas.martinez-carranza@karolinska.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Unicompartmental knee replacement; Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis; Other Names: Oxford
Experimental: 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.	Procedure: Total knee replacement; Participants with a medial gonarthritis are operated with a total knee replacement; Other Names: PFC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Thigh muscle cross sectional area and radiological attenuation measured by CT	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Margareta Hedström, MD,PhD, CLINTEC, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Health-related quality of life (HRQoL); Total knee replacement (TKR); Total knee arthroplasty (TKA); Medial gonarthritis, knee osteoarthritis,; Muscle function, muscle mass, muscle atrophy; Unicondylar knee arthroplasty (UKA); Unicondylar knee replacement (UKR); Patient related outcome measurements (PROMs)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: UNITKAstudien2015