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Completed

NCT Number: NCT07620145

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UNC Charlotte

Charlotte, North Carolina, 28269, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Anterior heel wedge

Device

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.

Primary outcomes

  1. Gait biomechanics

    Time frame: From enrollment to the end of treatment at 4 weeks

    Participants will walk over level ground at a self-selected pace and one equivalent to average older adult walking speed.

Secondary outcomes

  1. Patient-reported outcomes

    Time frame: From baseline to the end of the intervention at 4 weeks

    Participants will complete the Knee Osteoarthritis Outcomes Survey (0-100, higher scores are better).

  2. Patient-reported outcomes

    Time frame: From baseline to the end of the intervention at 4 weeks

    Participants will complete a Global rating of change (-7 to 7, higher scores indicate more positive changes).

  3. Patient-reported outcomes

    Time frame: From baseline to the end of the intervention at 4 weeks

    Participants will complete the VR-12 (0-100 with higher scores indicating more optimal physical and mental well-being) .

  4. Patient-reported outcomes

    Time frame: From baseline to the end of the intervention at 4 weeks

    Participants will complete the International Physical Activity Questionnaire- Short Form (0- no max possible, higher scores indicate greater levels of physical activity).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Charlotte

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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