Skip to main content
OpenTrials
Completed

NCT Number: NCT04374968

Use of Blood Flow Restriction Therapy Following ACL Tear

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Sport Injury Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

West Bloomfield, Michigan, 48332, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood flood restriction cuff

Device

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

Primary outcomes

  1. Quadriceps Strength

    Time frame: Three months

    Quadriceps strength via handheld dynamometer

Secondary outcomes

  1. Quadriceps Strength

    Time frame: six months

    Quadriceps strength via handheld dynamometer

  2. Knee range of motion

    Time frame: three months

    Knee range of motion via goniometer

  3. Knee range of motion

    Time frame: six months

    Knee range of motion via goniometer

  4. 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

  5. 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

  6. international knee documentation committee questionnaire

    Time frame: three months

    international knee documentation committee questionnaire, scale 0-100 with higher scores better

  7. international knee documentation committee questionnaire

    Time frame: six months

    international knee documentation committee questionnaire, scale 0-100 with higher scores better

  8. Pain scores

    Time frame: three months

    Visual analog scale pain scores, scale 0-10 higher is more pain

  9. Pain scores

    Time frame: six months

    Visual analog scale pain scores, scale 0-10 higher is more pain

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 5, 2020
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.