Blood Flow Restriction Following ACLR w/Quad Autograft

• Conditions: Autografts; Blood Flow Restriction Therapy; Rehabilitation Outcome; Quadriceps Muscle Strength; Anterior Cruciate Ligament Reconstruction
• Interventions: Other: Not applicable- observational study

• Registration Number: NCT06636045
• Lead Sponsor: University of Kansas Medical Center

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)

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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-09-05
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-10
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BFR Group	Not applicable- observational study	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.
Control Group	Not applicable- observational study	This group will perform physical therapy without the use of BFR

Primary Outcome Measures

Name	Time	Method
Quad muscle Strength	At 6 week post surgical timepoints	Compare the muscle strength gain or loss between BFR group and control group
Return to sport	6 week intervals	Compare the time it takes participants to return to sport in BFR group to control group

Trial Locations

Locations (1)

University of Kansas medical Center; 🇺🇸 Kansas City, Kansas, United States