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NCT07620145 · ClinicalTrials.gov registry record · Early Phase 1
Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty
A Early Phase 1 study, sponsored by University of North Carolina, Charlotte.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT07620145 is a Early Phase 1 study that has completed, run by University of North Carolina, Charlotte. The registered enrollment target is 8 participants.
The verdict
NCT07620145, a Early Phase 1 study, has completed, sponsored by University of North Carolina, Charlotte.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Anterior heel wedge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07620145
The ClinicalTrials.gov registry entry for NCT07620145 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Charlotte, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anterior heel wedge is the first listed.
NCT07620145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07620145 about?
NCT07620145 is a clinical study titled "Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty". 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 State...
What is the current status of trial NCT07620145?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2023-03-16. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT07620145?
The interventions under investigation include: Anterior heel wedge (DEVICE).
Who is sponsoring clinical trial NCT07620145?
This trial is sponsored by University of North Carolina, Charlotte, which has 13 total clinical trials registered on ClinicalTrials.gov.
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