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COMPLETED
NCT07620145
EARLY_PHASE1

Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty

Sponsor: University of North Carolina, Charlotte

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy of Anterior Heel Wedge at Reducing Knee Flexion Contracture After Total Knee Arthroplasty: A Pilot Investigation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2023-03-16

Completion Date

2025-12-31

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DEVICE

Anterior heel wedge

A continuously-worn shoe anterior heel wedge that fits on the under surface of the shoe just under the toe box. When worn during walking, the anterior heel wedge may help to increase knee joint range of motion and reduce knee flexion contracture in patients after total knee arthroplasty.

Locations (1)

UNC Charlotte

Charlotte, North Carolina, United States