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Enrolling by invitation NCT06636045

Blood Flow Restriction Following ACLR w/Quad Autograft

Observational Autografts Blood Flow Restriction Therapy Rehabilitation Outcome Quadriceps Muscle Strength

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Autografts, Blood Flow Restriction Therapy, Rehabilitation Outcome, Quadriceps Muscle Strength. Basic parameters: 14 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Blood Flow Restriction (BFR) on Rehabilitation Protocols Following Anterior Cruciate Ligament Reconstruction (ACLR) With Quadricep Autograft

Overview

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)

Detailed description

Specific Aim 1 will identify the overall preservation of muscle and changes in body composition after injury and throughout surgical rehabilitation in athletes undergoing ACL reconstruction. It is hypothesized that implementing BFR rehabilitation protocols following ACL reconstruction with autografts will expedite recovery and return to sport and rescue of muscle tissue at the donor site.

Specific Aim 2 will monitor muscle strength and activation following ACL reconstruction with performance of standardized assessments at intervals. It is hypothesized that BFR implementation will show greater return to strength and enhanced muscle activation during testing.

Interventions

  • Other Not applicable- observational study
    No intervention. Observational study.

Primary outcome measures

  • Quad muscle Strength [Time frame: At 6 week post surgical timepoints]
  • Return to sport [Time frame: 6 week intervals]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Kansas medical Center — Kansas City

Publications

  • 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
  • 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
  • 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 PMID 31301034
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06636045 · UKansasMCRI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗