Use of Blood Flow Restriction Therapy Following ACL Tear

Henry Ford Health

Status: Completed

Conditions: Knee Injuries; Anterior Cruciate Ligament Tear; Sport Injury

Treatments: Device: Blood flood restriction cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT04374968

13080

Details and patient eligibility

About

Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear

Full description

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.

The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ACL tear undergoing reconstruction

Exclusion criteria

• History of pulmonary embolism
• History of deep vein thrombosis
• Family history of PE/DVT
• Hypercoaguable disorder
• Multiligamentous knee injury
• Neurovascular injury
• Peripheral vascular disease
• Unable to complete physical therapy
• Unable to tolerate blood flow restriction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

BFR Treatment

Experimental group

Description:

Patients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR.

Treatment:

Device: Blood flood restriction cuff

Control

No Intervention group

Description:

The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery.