Home stretching device may prevent second knee surgery

NCT ID NCT07454356

Symptom relief Sponsor: Ermi LLC Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether adding a home stretching device to standard physical therapy helps people regain knee bending after total knee replacement. About 150 adults with limited knee motion will either use the device daily plus attend therapy, or do therapy alone. Researchers will track knee flexibility, pain, and daily function for up to two years to see if the device reduces the need for a second surgery.

What this could mean

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

Active substance: Hydraulic high-intensity stretch device (Ermi Knee Flexionater)
What this could lead to: If it works, this could help people regain knee movement after replacement and reduce the need for a second surgery to fix stiffness.
What could go wrong: This is a relatively small, early-stage trial. The device may not provide significant benefit over physical therapy alone, and results may not apply to all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

40 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: * Age 40 years or older * Undergoing primary total knee replacement surgery * Knee flexion less than 105 degrees at approximately 4 weeks after surgery * Considered a candidate for motion-restoring surgery, with any surgery delayed until after 2 months of nonoperative treatment Exclusion Criteria: * Not willing to participate * Diagnosis of advanced rheumatoid arthritis * Neurological deficit affecting the operative leg * Revision total knee replacement or previous major surgery on the same knee * Cognitive impairment * Prior total hip replacement on the same side (ipsilateral total hip arthroplasty) * Living more than 2 hours from the study site or unwilling to attend required local physical therapy visits

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As listed by the trial registrant

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

Joint contractures Knee arthrofibrosis Total knee anthroplasty

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Home stretching device may prevent second knee surgery

What the study statuses mean