Use of Blood Flow Restriction Therapy Following ACL Tear

Overview

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

Full Title of Study: “Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 1, 2022

Detailed 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.

Interventions

  • Device: Blood flood restriction cuff
    • Blood flow restriction cuffs will be used as an augment to physical therapy

Arms, Groups and Cohorts

  • Experimental: BFR Treatment
    • 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.
  • No Intervention: Control
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Quadriceps Strength
    • Time Frame: Three months
    • Quadriceps strength via handheld dynamometer

Secondary Measures

  • Quadriceps Strength
    • Time Frame: six months
    • Quadriceps strength via handheld dynamometer
  • Knee range of motion
    • Time Frame: three months
    • Knee range of motion via goniometer
  • Knee range of motion
    • Time Frame: six months
    • Knee range of motion via goniometer
  • Patient reported outcome measurement information system
    • Time Frame: Three months
    • Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better
  • Patient reported outcomes measurement information system
    • Time Frame: Six months
    • Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better
  • international knee documentation committee questionnaire
    • Time Frame: three months
    • international knee documentation committee questionnaire, scale 0-100 with higher scores better
  • international knee documentation committee questionnaire
    • Time Frame: six months
    • international knee documentation committee questionnaire, scale 0-100 with higher scores better
  • Pain scores
    • Time Frame: three months
    • Visual analog scale pain scores, scale 0-10 higher is more pain
  • Pain scores
    • Time Frame: six months
    • Visual analog scale pain scores, scale 0-10 higher is more pain

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Henry Ford Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joseph Tramer, Resident Investigator – Henry Ford Health System

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