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Simple shoe wedge may fix stiff knees after replacement

NCT ID NCT07620145

Symptom relief Sponsor: University of North Carolina, Charlotte Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a simple shoe wedge worn under the toes to help people straighten their knee after total knee replacement. Eight adults with a stiff knee (unable to fully straighten it) wore the wedge during walking for 4 weeks. The goal was to see if the wedge could reduce the knee stiffness without needing more surgery or anesthesia. This early study aims to guide future, larger research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
anterior heel wedge (a shoe attachment worn under the toes)
What this could lead to
If it works, this could offer a simple, non-surgical way to improve knee straightening after knee replacement, avoiding additional surgery or anesthesia.
What could go wrong
This is a very small pilot study with only 8 participants and no comparison group. The device may not work for everyone, and results may not apply to a broader population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

8 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee flexion contracture Total knee arthroplasty (TKA)

Contacts and locations

Locations

  • UNC Charlotte

    Charlotte, North Carolina, 28269, United States

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