Use of Blood Flow Restriction Therapy Following ACL Tear

Not Applicable

Completed

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

• Registration Number: NCT04374968
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Study Start: 2020-07-28
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quadriceps Strength	Three months	Quadriceps strength via handheld dynamometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 West Bloomfield, Michigan, United States