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ACTIVE NOT RECRUITING
NCT04913987
NA

Unicompartmental Versus Total Knee Replacement for Medial Compartment Knee Osteoarthritis

Sponsor: Golden Jubilee National Hospital

View on ClinicalTrials.gov

Summary

For patients with osteoarthritis affecting only the inner part of the knee, surgeons can offer either a partial knee replacement, which resurfaces the worn compartment alone, or a total knee replacement. Both are recommended treatments, but there is no agreement on when to choose one over the other. Partial knee replacement preserves the anterior cruciate ligament and more of the natural knee, and recovery is usually quicker, but it is used in only about one in ten knee replacements in the United Kingdom. Studies comparing the two have mostly relied on patient questionnaires, which may not be sensitive enough to detect differences in how the knee actually functions. Studies that have measured movement directly have concentrated on level walking, which is not demanding enough to separate the two operations. Difficulty with stairs is one of the longest lasting problems patients report after knee replacement. The FLEX-UNI trial will compare the two operations using three-dimensional motion analysis during more demanding everyday activities. Forty patients who are suitable for a partial knee replacement will be randomly allocated to receive either a partial or a total knee replacement. Patients and the researchers measuring their movement will not know which operation was performed. The main measurement is how far the operated knee bends while stepping down from a 20 cm step, measured one year after surgery. Movement during walking, stair climbing, slopes, sitting and standing, and balance will also be measured, along with questionnaires, x-rays, and complications. Results will be compared against measurements from people with healthy knees.

Official title: A Functional, Clinical, and Biomechanical Examination of Unicompartmental Versus Total Knee Arthroplasty for Medial Compartment Knee Osteoarthritis (FLEX-UNI): A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-04-26

Completion Date

2027-10-15

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DEVICE

Persona Partial Knee (PPK)

Cemented medial fixed-bearing unicompartmental knee arthroplasty using the Persona Partial Knee (PPK; Zimmer Biomet, Warsaw, Indiana, USA).

DEVICE

Triathlon cruciate-retaining total knee system.

Cemented Triathlon cruciate-retaining total knee system without patellar resurfacing (Stryker, Mahwah, New Jersey, USA).

Locations (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, United Kingdom