Image

Knee Flexionater to Avoid Motion Restoring Surgery

Knee Flexionater to Avoid Motion Restoring Surgery

Recruiting
40 years and older
All
Phase N/A

Powered by AI

Overview

The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery.

Some people have difficulty bending their knee during recovery. When this happens, doctors may recommend another procedure called motion-restoring surgery to improve knee movement.

This study aims to answer two main questions. First, does adding a hydraulic high-intensity stretching device to physical therapy help people regain knee bending after surgery? Second, does using the device affect recovery, daily activities, or the chance of needing another procedure?

Researchers will compare two treatment approaches. One group will receive standard physical therapy alone. The other group will receive standard physical therapy and will also use a hydraulic high-intensity stretching device called the Ermi Knee Flexionater at home.

Participants who receive the device will use it at home each day in addition to attending their physical therapy sessions. Researchers will measure how well participants can bend their knee and will ask questions about pain, daily function, and activity level. Participants will also complete simple walking and mobility tests.

Study visits will occur about four weeks after surgery when participants enroll, and again at about eight weeks, twelve weeks, six months, one year, and two years after surgery. Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement.

Eligibility

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

Study details
    Joint Contractures
    Total Knee Anthroplasty
    Knee Arthrofibrosis

NCT07454356

Ermi LLC

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.