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Blood Flow Restriction Following ACLR w/Quad Autograft (BFR Quad Delay)

University of Kansas logo

University of Kansas

Status

Invitation-only

Conditions

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

Treatments

Other: Not applicable- observational study

Study type

Observational

Funder types

Other

Identifiers

NCT06636045
UKansasMCRI

Details and patient eligibility

About

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)

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

14 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Sharon Bradshaw

Data sourced from clinicaltrials.gov

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