Status:
WITHDRAWN
BFR Therapy After ACL Reconstruction
Lead Sponsor:
Steadman Philippon Research Institute
Conditions:
ACL Injury
Quadriceps Muscle Atrophy
Eligibility:
All Genders
14-70 years
Phase:
NA
Brief Summary
This study is a prospective, double-blinded, randomized control trial examining the effect of blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in patients undergoing ...
Detailed Description
Patients will be randomized to either BFR therapy or no BFR therapy. Randomization will be carried out using block randomization with blocks of 6. Those undergoing BFR therapy will have a Delfi Perso...
Eligibility Criteria
Inclusion
- Age 14-70
- Undergoing ACL reconstruction with patellar tendon autograft
- Full weightbearing after surgery
- Surgery performed within 14 days of ACL injury
- No nerve catheter in place
Exclusion
- Meniscal root tears
- radial meniscal tears
- multi-ligament knee injury
- revision ACL reconstruction
- concomitant osteotomies
- concomitant cartilage resurfacing procedures
- fracture preventing full-weightbearing of operated extremity
- previous history of deep vein thrombosis (DVT)
- new nerve injury/findings affecting operative extremity
- active femoral nerve catheter
- nerve block lasting longer than day of surgery
- patients unable to tolerate BFR treatment
- untolerable post-operative pain due to absence of nerve catheter
- proximal thigh girth greater than 34cm
- time to surgery greater than 14 days
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03794570
Start Date
December 18 2018
End Date
June 1 2019
Last Update
December 4 2019
Active Locations (1)
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1
The Steadman Clinic
Vail, Colorado, United States, 81657