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AutograftsBFR Quad DelayNCT06636045

Blood Flow Restriction Following ACLR w/Quad Autograft

An observational study of Autografts and Blood Flow Restriction Therapy, run by University of Kansas Medical Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 40 years
What is being tested?
Not applicable- observational study
How many people
40 participants
Where
1 siteUnited States
Study dates
5 Sep 2024to Jun 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Kansas medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

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

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)

Read the 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.

Being tested
Not applicable- observational study
Keywords
blood flow restriction, anterior cruciate ligament reconstruction, quadriceps muscle strength

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not applicable- observational studyOther

    No intervention. Observational study.

Study groups in NCT06636045
Study groupRoleWhat they receive
BFR GroupBlood 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.
Receives: Other: Not applicable- observational study
Control GroupThis group will perform physical therapy without the use of BFR
Receives: Other: Not applicable- observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quad muscle Strength

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

    Measured: At 6 week post surgical timepoints

  2. Return to sport

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

    Measured: 6 week intervals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start5 Sep 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636045
Sponsor's protocol ID
UKansasMCRI
Acronym
BFR Quad Delay
Status last verified
Aug 2024
First submitted
8 Oct 2024
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be de-identified and compiled prior to analysis, therefore no individual data will be shared.

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.

    PubMed 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.

    PubMed 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: 10.1007/s40279-019-01137-2.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 37468645

  • 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.

    PubMed 30874836

Questions about this trial

What is this clinical trial studying?

An observational study of Autografts and Blood Flow Restriction Therapy, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quad muscle Strength (time frame: At 6 week post surgical timepoints). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636045, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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