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Use of Blood Flow Restriction Therapy Following ACL Tear

Primary Purpose

Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flood restriction cuff
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BFR Treatment

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quadriceps Strength
Quadriceps strength via handheld dynamometer

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2020
Last Updated
July 18, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04374968
Brief Title
Use of Blood Flow Restriction Therapy Following ACL Tear
Official Title
Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial with a treatment and control group
Masking
Outcomes Assessor
Masking Description
Participant and investigator will be aware of treatment arm allocation. Outcomes will be assessed in a masked fashion
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFR Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Blood flood restriction cuff
Intervention Description
Blood flow restriction cuffs will be used as an augment to physical therapy
Primary Outcome Measure Information:
Title
Quadriceps Strength
Description
Quadriceps strength via handheld dynamometer
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Quadriceps Strength
Description
Quadriceps strength via handheld dynamometer
Time Frame
six months
Title
Knee range of motion
Description
Knee range of motion via goniometer
Time Frame
three months
Title
Knee range of motion
Description
Knee range of motion via goniometer
Time Frame
six months
Title
Patient reported outcome measurement information system
Description
Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better
Time Frame
Three months
Title
Patient reported outcomes measurement information system
Description
Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better
Time Frame
Six months
Title
international knee documentation committee questionnaire
Description
international knee documentation committee questionnaire, scale 0-100 with higher scores better
Time Frame
three months
Title
international knee documentation committee questionnaire
Description
international knee documentation committee questionnaire, scale 0-100 with higher scores better
Time Frame
six months
Title
Pain scores
Description
Visual analog scale pain scores, scale 0-10 higher is more pain
Time Frame
three months
Title
Pain scores
Description
Visual analog scale pain scores, scale 0-10 higher is more pain
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Henry Ford Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48332
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Blood Flow Restriction Therapy Following ACL Tear

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