Knee Extension Device for ACL Reconstruction

AM
CC
Overseen ByCamille Crane
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Alabama at Birmingham
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 the Ermi Knee Extensionater, a new knee stretching device, can enhance recovery after ACL (anterior cruciate ligament) surgery. The researchers aim to determine if using this device at home, alongside regular physical therapy, improves knee extension. One group will use the device with standard therapy, while another group will receive only standard therapy. Individuals who have had an ACL tear, but not a revision surgery, and are undergoing their first ACL reconstruction might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to benefit from this innovative approach.

What prior data suggests that the Ermi Knee Extensionater is safe for knee extension recovery?

Research shows that the Ermi Knee Extensionater is generally well-tolerated by patients recovering from ACL surgery. Studies have found that devices like the Ermi can greatly improve knee movement after surgery, more so than gentler stretching methods.

Detailed safety information for the Ermi Knee Extensionater isn't widely available, as the device is currently being tested in an early-phase trial. This phase primarily ensures that treatments are safe for use. So far, no specific evidence of major side effects from using this device has emerged.12345

Why are researchers excited about this trial?

The Ermi Knee Extensionater is unique because it enhances standard ACL rehabilitation by allowing patients to perform terminal extension stretching at home. Unlike typical physical therapy, which relies solely on in-clinic exercises and clinician-guided protocols, this device enables daily, consistent stretching, potentially speeding up recovery. Researchers are excited because this method could improve range of motion and knee function more effectively than standard care alone, offering a more active role for patients in their recovery process.

What evidence suggests that the Ermi Knee Extensionater is effective for improving knee extension after ACL reconstruction?

Research shows that the Ermi Knee Extensionater can improve knee movement after ACL (anterior cruciate ligament) surgery. In this trial, some participants will use the Ermi Knee Extensionater alongside their regular physical therapy. Earlier studies have shown that patients using this device with their regular therapy regained full knee movement faster than those relying solely on physical therapy. Fully straightening the knee is crucial for a successful recovery after ACL surgery. The device enhances recovery by providing strong stretching exercises at home, complementing regular physical therapy sessions. These early findings suggest that the Ermi Knee Extensionater could be a valuable tool for recovery after ACL surgery.

Who Is on the Research Team?

AM

Amit Momaya, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people who have had ACL reconstruction surgery on their knee and are looking to regain full knee extension. Participants should be able to take part in physical therapy after surgery.

Inclusion Criteria

I am between 14 and 65 years old.
I had my first ACL surgery using my own bone-tendon-bone tissue.
I have had an ACL tear that was treated without surgery.

Exclusion Criteria

I have a nerve-related problem affecting my legs.
I am having a repeat ACL surgery.
I am unable to finish a rehabilitation program.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard physical therapy with or without the Ermi Knee Extensionater for knee extension recovery

3 months
Regular visits as per standard ACL protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ermi Knee Extensionater

Trial Overview

The study compares standard physical therapy alone versus standard physical therapy plus a home-based high-intensity stretching device (Ermi Knee Extensionater) to see which helps patients recover full knee extension better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Patient Receiving Ermi Knee Extensionator + Standard of CareExperimental Treatment2 Interventions
Group II: Participants Receiving Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Ermi LLC

Industry Sponsor

Citations

Recovery of knee extension and incidence of ... - PMC - NIH

Lack of full extension following ACL rupture may contribute to functional deficits and an increased risk of osteoarthritis [7]. However, the point at which ...

ACL Reconstruction Outcomes | SHELBOURNE KNEE CENTER

The results of this study showed that patients with abnormal knee extension at 2 months postoperative were 6.4 times more likely to have abnormal knee extension ...

Considerations with Open Kinetic Chain Knee Extension ...

We routinely prescribe this exercise for our patients following ACL surgery. However, being too aggressive (maximum effort or high force ...

Patient-actuated End Range Motion Stretching Devices

ERMI devices improves range of motion (ROM) more than lower intensity stretching devices in patients who are post-knee injury or surgery.

Restoration of Knee Extension After ACL Reconstruction

The purpose of this study is to determine whether the addition of a home-based high-intensity knee extension stretching device (Ermi Knee ...