Use of Blood Flow Restriction Therapy Following ACL Tear

NCT ID: NCT04374968

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2022-05-01

Brief Summary

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

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.

Conditions

Anterior Cruciate Ligament Tear; Knee Injuries; Sport Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood flood restriction cuff

Intervention Type: DEVICE

Blood flow restriction cuffs will be used as an augment to physical therapy

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Blood flood restriction cuff

Blood flow restriction cuffs will be used as an augment to physical therapy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Joseph Tramer

Resident Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Hospital

West Bloomfield, Michigan, United States

Countries

United States

References

Okoroha KR, Tramer JS, Khalil LS, Jildeh TR, Abbas MJ, Buckley PJ, Lindell C, Moutzouros V. Effects of a Perioperative Blood Flow Restriction Therapy Program on Early Quadriceps Strength and Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 Nov 27;11(11):23259671231209694. doi: 10.1177/23259671231209694. eCollection 2023 Nov.

Reference Type: DERIVED

PMID: 38035216 (View on PubMed)

Other Identifiers

13080

Identifier Type: -

Identifier Source: org_study_id