Restoration of Knee Extension After ACL Reconstruction

NCT07685561 | Not Yet Recruiting Phase 1 FDA Device

• 2 other identifiers: IRB-300016352ERMI LLC Device
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the addition of a home-based high-intensity knee extension stretching device (Ermi Knee Extensionater) to standard postoperative physical therapy improves recovery of full knee extension following ACL reconstruction compared with standard physical therapy alone.

Conditions

Knee; ACL

Keywords

ACL; Knee; knee reconstruction; Ermi Knee Extensionator

Outcome Measures

Primary Outcomes (1)

• Changes in Knee Range of Motion

  A goniometer will be used to measure the post operative knee's range of motion an angle or to rotate an object to a precise angular position.

  Baseline, 2 weeks, 6 weeks, and 3 months

Study Arms (2)

Participants Receiving Standard of Care

ACTIVE COMPARATOR

Patients will receive standard physical therapy alone: postoperative rehabilitation as per the treating clinician's standard ACL protocol (this may include use of the Knee Extensionater in a clinical setting).

Behavioral: Standard Physical Therapy

Patient Receiving Ermi Knee Extensionator + Standard of Care

EXPERIMENTAL

Patients will receive the Ermi Knee Extensionater plus standard physical therapy: Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching.

Behavioral: Standard Physical Therapy; Device: Ermi Knee Extensionater

Interventions

Standard Physical Therapy BEHAVIORAL

Routine standard physical therapy for post op knee reconstructive surgery. May include use of knee Extensionator in a clinic setting.

Participants Receiving Standard of Care; Patient Receiving Ermi Knee Extensionator + Standard of Care

Ermi Knee Extensionater DEVICE

Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching. The Ermi device will be distributed to all participants in Arm 2 preoperatively. Stretching protocols will be provided at this time. Following surgery, participants must complete daily home stretching sessions (60 total minutes of end-range stretching per day) starting at postoperative day one. Each stretching session is broken down into 10 minutes of stretching, followed by 10 minutes of rest. This is repeated throughout the day until a total of 60 minutes of stretching is completed. There should be at least one hour between sessions. Stretching sessions will continue until 3 months postop.

Patient Receiving Ermi Knee Extensionator + Standard of Care

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 14-65 yo
• Primary ACLR (BTB auto ONLY)
• Prior ACL tear treated non-op

You may not qualify if:

• Revision ACL surgery
• Major concomitant ligament reconstruction
• Neurologic lower-extremity disorder
• Inability to complete rehab
• Cognitive impairment preventing consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Ermi LLC: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

Study Officials

• Amit Momaya, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Momaya, MD

CONTACT

(205) 930-8494; amomaya@uabmc.edu

Camille Crane

CONTACT

303-652-7821; camillecrane@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

US (1)