150 Participants NeededMy employer runs this trial

Knee Flexionater for Total Knee Replacement Recovery

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new stretching device can enhance recovery after knee replacement surgery. It compares standard physical therapy with a combination of therapy and the use of the Ermi Knee Flexionater, a hydraulic stretching device, at home. The goal is to determine if the device improves knee bending, enhances daily activities, and reduces the need for additional surgery. Individuals who have undergone knee replacement surgery and struggle to bend their knee beyond 105 degrees about four weeks post-surgery might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative recovery methods for knee replacement patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Ermi Knee Flexionater is safe for use in knee replacement recovery?

Research has shown that the Ermi Knee Flexionater, a device designed to stretch the knee, has been safely used by patients recovering from knee surgery. Studies found that 92% of patients using this device experienced significant improvements in knee bending, with only 2% requiring additional surgery. This indicates that the device is generally well-tolerated and can enhance knee movement. As a non-surgical treatment used at home, it reduces the risk of surgical complications. While some discomfort from the stretching may occur, studies have not reported serious side effects.12345

Why are researchers excited about this trial?

The Ermi Knee Flexionater is unique because it combines standard physical therapy with a hydraulic high-intensity stretch device, potentially enhancing recovery after total knee replacement. Unlike traditional rehabilitation that relies solely on exercises with a therapist, this device allows patients to continue their therapy at home, providing consistent high-intensity stretching. Researchers are excited about this approach as it may improve knee flexibility and function more efficiently, offering a new avenue for faster and possibly more effective recovery compared to standard physical therapy alone.

What evidence suggests that the Ermi Knee Flexionater is effective for improving knee bending after total knee replacement?

Research has shown that the Ermi Knee Flexionater can significantly aid knee bending after surgery. In this trial, participants in one arm will use the Ermi Knee Flexionater alongside standard postoperative physical therapy. Studies have found that this device helps patients regain more knee movement compared to regular physical therapy alone. Some studies report that it successfully improves knee movement in 90% of cases. The Ermi Knee Flexionater employs strong stretching techniques, which effectively treat knee stiffness and prevent the need for additional surgery. Overall, this device appears to speed up recovery, helping people return to their daily activities sooner.12456

Who Is on the Research Team?

SK

Shaun K Stinton, PhD

Principal Investigator

Ermi LLC

Are You a Good Fit for This Trial?

This trial is for people aged 40 or older who have had a total knee replacement and, about four weeks after surgery, still can't bend their knee past 105 degrees. They must be candidates for motion-restoring surgery but willing to try non-surgical treatment first. Certain health conditions or living far from the study site may exclude participation.

Inclusion Criteria

I am 40 years old or older.
I am having my knee replaced for the first time.
My knee bends less than 105 degrees about 4 weeks after surgery.
See 1 more

Exclusion Criteria

I live more than 2 hours away or cannot attend local physical therapy visits.
I do not want to take part in this clinical trial.
I have been diagnosed with advanced rheumatoid arthritis.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive standard physical therapy, with one group also using a hydraulic high-intensity stretch device at home

8 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

2 years
6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ermi Knee Flexionater

Trial Overview

The study compares standard physical therapy alone versus physical therapy plus daily use of a hydraulic stretching device (the Ermi Knee Flexionater) at home. The goal is to see if adding the device helps improve knee bending and recovery after knee replacement.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Hydraulic high-Intensity Stretch Device Plus Standard Physical TherapyExperimental Treatment1 Intervention
Group II: Physical Therapy OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ermi LLC

Lead Sponsor

Citations

Knee Flexionater to Avoid Motion Restoring Surgery

Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement. Official ...

High-intensity mechanical therapy for loss of knee extension ...

We conclude that the adjunctive use of HIS mechanical therapy is an effective treatment option for patients with knee flexion contractures.

ERMI Devices | Peer-reviewed studies showing 90% success

Patented ERMI devices deliver proven, FDA-cleared range-of-motion recovery backed by peer-reviewed studies showing 90% success and up to $9k savings per ...

Knee Flexionater for Total Knee Replacement Recovery

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

Patient-Controlled End of Range Motion Stretching Devices

One small RCT and 1 larger retrospective comparative study have reported that high-intensity stretching with ERMI devices improved ROM more than lower intensity ...

6.

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Achieve over 90% surgery avoidance and save costs for payors

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