Use of Blood Flow Restriction Therapy Following ACL Tear

Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear

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

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Tear; Knee Injuries; Sport Injury
• Intervention / Treatment: Device: Blood flood restriction cuff

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Tramer, MD; Phone Number: 2165362904; Email: jtramer7@gmail.com

Study Locations

• United States
  • Michigan
    • West Bloomfield, Michigan, United States, 48332
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Blood flood restriction cuff; Blood flow restriction cuffs will be used as an augment to physical therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Strength	Quadriceps strength via handheld dynamometer	Three months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries; Knee Injuries
• Other Study ID Numbers: 13080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes