Use of Blood Flow Restriction Therapy Following ACL Tear

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374968
• Other study ID #: 13080
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear
• Athletic Injuries
• Knee Injuries
• Sport Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps Strength	Quadriceps strength via handheld dynamometer	Three months
Secondary	Quadriceps Strength	Quadriceps strength via handheld dynamometer	six months
Secondary	Knee range of motion	Knee range of motion via goniometer	three months
Secondary	Knee range of motion	Knee range of motion via goniometer	six months
Secondary	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
Secondary	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
Secondary	international knee documentation committee questionnaire	international knee documentation committee questionnaire, scale 0-100 with higher scores better	three months
Secondary	international knee documentation committee questionnaire	international knee documentation committee questionnaire, scale 0-100 with higher scores better	six months
Secondary	Pain scores	Visual analog scale pain scores, scale 0-10 higher is more pain	three months
Secondary	Pain scores	Visual analog scale pain scores, scale 0-10 higher is more pain	six months