Use of Blood Flow Restriction Therapy Following ACL Tear

NCT04374968 | Completed FDA Device

• 1 other identifier: 13080
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anterior Cruciate Ligament Tear; Knee Injuries; Sport Injury

Outcome Measures

Primary Outcomes (1)

• Quadriceps Strength

  Quadriceps strength via handheld dynamometer

  Three months

Secondary Outcomes (9)

• Quadriceps Strength

  six months

• Knee range of motion

  three months

• Knee range of motion

  six months

• Patient reported outcome measurement information system

  Three months

• Patient reported outcomes measurement information system

  Six months

Study Arms (2)

BFR Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Blood flood restriction cuff DEVICE

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

BFR Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ACL tear undergoing reconstruction

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

West Bloomfield, Michigan, 48332, United States

Location

Related Publications (1)

• Okoroha KR, Tramer JS, Khalil LS, Jildeh TR, Abbas MJ, Buckley PJ, Lindell C, Moutzouros V. Effects of a Perioperative Blood Flow Restriction Therapy Program on Early Quadriceps Strength and Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 Nov 27;11(11):23259671231209694. doi: 10.1177/23259671231209694. eCollection 2023 Nov.

  PMID: 38035216 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant and investigator will be aware of treatment arm allocation. Outcomes will be assessed in a masked fashion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Investigator

Model Details: Parallel randomized controlled trial with a treatment and control group

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: July 28, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)