Blood Flow Restriction Following ACLR w/Quad Autograft

NCT06636045 | Enrolling By Invitation

• 1 other identifier: UKansasMCRI
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This project is intended to acquire objective measurements of implementing BFR rehabilitation in ACL reconstructions to show any changes upon completion of the BFR protocol. The results in this study will hopefully represent valuable data in the support of using autografts for ACL reconstructions in high level athletes wanting a full recovery and return to high level of sport. It has been speculated that use of autografts in ACL reconstructions leads to more quad weakness and muscle atrophy due to tendon harvesting. (Slone et al., 2015) More recently, BFR has shown promise in expediting the recovery and rehabilitation process post-surgically. By implementing BFR following ACL reconstructions with autografts, we hope to mitigate the major deterrent for autograft use and giving patients a more cost-effective approach to surgery. (Hughes et al., 2019)

Conditions

Autografts; Blood Flow Restriction Therapy; Rehabilitation Outcome; Quadriceps Muscle Strength; Anterior Cruciate Ligament Reconstruction

Keywords

blood flow restriction; anterior cruciate ligament reconstruction; quadriceps muscle strength

Outcome Measures

Primary Outcomes (2)

• Quad muscle Strength

  Compare the muscle strength gain or loss between BFR group and control group

  At 6 week post surgical timepoints

• Return to sport

  Compare the time it takes participants to return to sport in BFR group to control group

  6 week intervals

Study Arms (2)

BFR Group

Blood Flow Restriction (BFR) will be administered in conjunction with regular physical therapy exercises. BFR training will begin as early as 2 weeks post-op. For 2-3 times/week, as indicated by the patient's physical therapist. This is part of standard practice. Each session will consist of 4 sets (30, 15, 15, and 15 reps) at 80% limb occlusion pressure.

Other: Not applicable- observational study

Control Group

This group will perform physical therapy without the use of BFR

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

No intervention. Observational study.

BFR Group; Control Group

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subject population will be patients of the University of Kansas Health System

You may qualify if:

• Patient undergoing anterior cruciate ligament construction utilizing a quadriceps autograft
• Age 14 - 40 years old

You may not qualify if:

• Comorbid conditions (i.e.: hypertension, diabetes, obesity, etc.)
• Patient taking blood thinners or at risk of embolism
• Revision anterior cruciate ligament construction
• Allograft based reconstruction
• Non-quadriceps graft

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (9)

• Das A, Paton B. Is There a Minimum Effective Dose for Vascular Occlusion During Blood Flow Restriction Training? Front Physiol. 2022 Apr 8;13:838115. doi: 10.3389/fphys.2022.838115. eCollection 2022.

  PMID: 35464074 BACKGROUND

• Lu Y, Patel BH, Kym C, Nwachukwu BU, Beletksy A, Forsythe B, Chahla J. Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2020 Mar 25;8(3):2325967120906822. doi: 10.1177/2325967120906822. eCollection 2020 Mar.

  PMID: 32232065 BACKGROUND

• Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007/s40279-019-01137-2.

  PMID: 31301034 BACKGROUND

• Slone HS, Romine SE, Premkumar A, Xerogeanes JW. Quadriceps tendon autograft for anterior cruciate ligament reconstruction: a comprehensive review of current literature and systematic review of clinical results. Arthroscopy. 2015 Mar;31(3):541-54. doi: 10.1016/j.arthro.2014.11.010. Epub 2014 Dec 25.

  PMID: 25543249 BACKGROUND

• Sim K, Rahardja R, Zhu M, Young SW. Optimal Graft Choice in Athletic Patients with Anterior Cruciate Ligament Injuries: Review and Clinical Insights. Open Access J Sports Med. 2022 Jul 1;13:55-67. doi: 10.2147/OAJSM.S340702. eCollection 2022.

  PMID: 35800660 BACKGROUND

• Cognetti DJ, Sheean AJ, Owens JG. Blood Flow Restriction Therapy and Its Use for Rehabilitation and Return to Sport: Physiology, Application, and Guidelines for Implementation. Arthrosc Sports Med Rehabil. 2022 Jan 28;4(1):e71-e76. doi: 10.1016/j.asmr.2021.09.025. eCollection 2022 Jan.

  PMID: 35141538 BACKGROUND

• Castle JP, Tramer JS, Turner EHG, Cotter D, McGee A, Abbas MJ, Gasparro MA, Lynch TS, Moutzouros V. Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. J Orthop. 2023 Mar 13;38:47-52. doi: 10.1016/j.jor.2023.03.007. eCollection 2023 Apr.

  PMID: 36969302 BACKGROUND

• Tang N, Eren M, Gurpinar T, Ozturkmen Y. A prospective randomized controlled study of hamstring and bone-free quadriceps tendons autografts in arthroscopic ACL reconstruction. Eur J Orthop Surg Traumatol. 2024 Jan;34(1):293-301. doi: 10.1007/s00590-023-03636-5. Epub 2023 Jul 19.

  PMID: 37468645 BACKGROUND

• Mistry H, Metcalfe A, Colquitt J, Loveman E, Smith NA, Royle P, Waugh N. Autograft or allograft for reconstruction of anterior cruciate ligament: a health economics perspective. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1782-1790. doi: 10.1007/s00167-019-05436-z. Epub 2019 Mar 14.

  PMID: 30874836 BACKGROUND

Related Links

• online sample size calculator

Study Officials

• Matthew Vopat, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopedic Surgery

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)