Use of Blood Flow Restriction Therapy Following ACL Tear

Sponsor

Henry Ford Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT04374968

Collaborator

(none)

Enrollment

Location

Arms

21.1

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Tear Knee Injuries Sport Injury	Device: Blood flood restriction cuff	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel randomized controlled trial with a treatment and control groupParallel randomized controlled trial with a treatment and control group

Masking:

Single (Outcomes Assessor)

Masking Description:

Participant and investigator will be aware of treatment arm allocation. Outcomes will be assessed in a masked fashion

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Blood flood restriction cuff Blood flow restriction cuffs will be used as an augment to physical therapy
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: Blood flood restriction cuff

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Quadriceps Strength [Three months]
Quadriceps strength via handheld dynamometer

Secondary Outcome Measures

Quadriceps Strength [six months]
Quadriceps strength via handheld dynamometer
Knee range of motion [three months]
Knee range of motion via goniometer
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
international knee documentation committee questionnaire [three months]
international knee documentation committee questionnaire, scale 0-100 with higher scores better
international knee documentation committee questionnaire [six months]
international knee documentation committee questionnaire, scale 0-100 with higher scores better
Pain scores [three months]
Visual analog scale pain scores, scale 0-10 higher is more pain
Pain scores [six months]
Visual analog scale pain scores, scale 0-10 higher is more pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	West Bloomfield	Michigan	United States	48332

Sponsors and Collaborators

Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph Tramer, Resident Investigator, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT04374968

Other Study ID Numbers:

13080

First Posted:

May 5, 2020

Last Update Posted:

Aug 25, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Wounds and Injuries

Knee Injuries

Athletic Injuries

Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Aug 25, 2021