An Early Phase 1 interventional study of Anterior heel wedge in Knee Flexion Contracture and Total Knee Arthroplasty (TKA), sponsored by University of North Carolina, Charlotte. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of North Carolina, Charlotte · Early Phase 1, Interventional, and Treatment
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.
University of North Carolina, Charlotte is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants enrolled in this arm wear an anterior heel wedge, in the form of a shoe orthotic, to improve walking and reduce knee flexion contracture. The wedge is worn continuously on the shoe for 1 month.
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.
Gait biomechanics
Participants will walk over level ground at a self-selected pace and one equivalent to average older adult walking speed.
Time frame: From enrollment to the end of treatment at 4 weeks
Patient-reported outcomes
Participants will complete the Knee Osteoarthritis Outcomes Survey (0-100, higher scores are better).
Time frame: From baseline to the end of the intervention at 4 weeks
Patient-reported outcomes
Participants will complete a Global rating of change (-7 to 7, higher scores indicate more positive changes).
Time frame: From baseline to the end of the intervention at 4 weeks
Patient-reported outcomes
Participants will complete the VR-12 (0-100 with higher scores indicating more optimal physical and mental well-being) .
Time frame: From baseline to the end of the intervention at 4 weeks
Patient-reported outcomes
Participants will complete the International Physical Activity Questionnaire- Short Form (0- no max possible, higher scores indicate greater levels of physical activity).
Time frame: From baseline to the end of the intervention at 4 weeks
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Charlotte