Restoration of Knee Extension After ACL Reconstruction

The University of Alabama at Birmingham

Status and phase: Begins enrollment this month; Phase 1

Conditions: ACL; Knee

Treatments: Behavioral: Standard Physical Therapy; Device: Ermi Knee Extensionater

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07685561

ERMI LLC Device (Other Identifier)

IRB-300016352

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Participants Receiving Standard of Care

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard Physical Therapy

Patient Receiving Ermi Knee Extensionator + Standard of Care

Experimental group

Description:

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.

Treatment:

Device: Ermi Knee Extensionater

Behavioral: Standard Physical Therapy