Knee Flexion ContractureEarly Phase 1NCT07620145

Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty

A Early Phase 1 study testing Anterior heel wedge in people with Knee Flexion Contracture and Total Knee Arthroplasty (TKA), run by University of North Carolina, Charlotte at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Knee Flexion Contracture, Total Knee Arthroplasty (TKA)
What is being tested?: Anterior heel wedge
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2023to 31 Dec 2025
Phase: Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

over the age of 18 years
underwent primary, unilateral TKA and approved for participation by surgeon
present with flexion contracture in the operative limb (5 degrees or greater at least 3 months after surgery)
body mass index <40kg/m^2

Who cannot join

underwent revision TKA
underwent bilateral TKA
require use of assistive device to walk
inability to consistently comprehend and repeat back directions, including for reasons of not understanding/speaking English
current smoker

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC Charlotte
Charlotte, North Carolina, 28269

Other trials in United States

About this study

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

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.

Conditions: Knee Flexion Contracture, Total Knee Arthroplasty (TKA)
Being tested: Anterior heel wedge
Keywords: walking, knee, range of motion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anterior heel wedgeDevice
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.

Study groups in NCT07620145
Study group	Role	What they receive
Orthotic	Experimental	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. Receives: Device: Anterior heel wedge

What is being measured

The primary outcome is the main question the study is designed to answer.

Gait biomechanics
Participants will walk over level ground at a self-selected pace and one equivalent to average older adult walking speed.
Measured: From enrollment to the end of treatment at 4 weeks

Secondary outcomes (4)

Patient-reported outcomes
Participants will complete the Knee Osteoarthritis Outcomes Survey (0-100, higher scores are better).
Measured: 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).
Measured: 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) .
Measured: 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).
Measured: From baseline to the end of the intervention at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202331 Dec 2025

First posted2 Jun 2026
Study start16 Mar 2023
Primary completion31 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee Flexion ContractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07620145
Sponsor's protocol ID: 22-1206
Status last verified: May 2026
First submitted: 19 Dec 2024
Last updated: 2 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sappey-Marinier E, Fernandez A, Shatrov J, Batailler C, Servien E, Huten D, Lustig S. Management of fixed flexion contracture in primary total knee arthroplasty: recent systematic review. SICOT J. 2024;10:11. doi: 10.1051/sicotj/2024007. Epub 2024 Mar 26.
PubMed 38530205