Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty

Completed · Early Phase 1

Conditions studied: Knee Flexion Contracture, Total Knee Arthroplasty (TKA)

In brief

Total knee arthroplasty (TKA) remains the only treatment for end-stage knee osteoarthritis, whereby the diseased ends of the bones comprising the knee joint are removed and replaced with prosthetic joint components. Approximately 500,000 of these procedures are performed annually in the United States. Despite an otherwise successful procedure and post-operative rehabilitation process, about 5% of all individuals will develop a flexion contracture after TKA. Flexion contracture limits the knee joint range of motion, which has negative impacts on activities of daily living and health-related quality of life. Standard of care treatment for resolving flexion contracture requires more surgery or, at minimum, more exposure to anesthesia to manipulate the joint and improve range of motion. The investigators have developed a non-invasive means for resolving flexion contracture, The investigators propose fixing a wedge to the sole of the patient's shoe such that the taller end of the wedge is located near the toes and the shorter end is closer to the heel. Biomechanically, this forces the individual to make ground contact during walking closer to the heel rather than the toes (which is typically observed in patients with flexion contracture). By forcing ground contact closer to the heel, patients gradually force their knee to extend (straighten) over time and resolve the flexion contracture. The aim of this pilot investigation is to test the hypothesis that the anterior wedge worn on the shoe during all walking activities for 4 weeks will reduce the severity of the flexion contracture in patients after TKA.

Key facts

Study ID
NCT07620145
Run by
University of North Carolina, Charlotte
People needed
8
Starts
2023-03-16
Expected to finish
2025-12-31
Last updated by the study team
2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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