Blood Flow Restriction Following ACLR w/Quad 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)

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Key information

Conditions

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

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable- observational study

Other

No intervention. Observational study.

Primary outcomes

Quad muscle Strength

Time frame: At 6 week post surgical timepoints

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

Time frame: 6 week intervals

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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: BFR Quad Delay

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Oct 10, 2024
Registry last updated: Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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