Clinical trial NCT04519801: BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft
Official title: Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Injury
Keywords: BFR
ACLR
Quadriceps Tendon
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: American Orthopaedic Society for Sports Medicine
name: Congressionally Directed Medical Research Programs
First posted: 2020-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme.
Primary purpose: TREATMENT

Brief summary: The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 12 weeks, and at 52 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 24 weeks, 36 weeks, and 52 weeks post-operative (secondary outcome measures).

Detailed description: The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following ACLR standardized with respect to both surgical technique and graft selection. The investigator's central hypothesis is that the addition of BFR therapy has the potential to accelerate surgical recovery, expedite return-to-duty, and maximize medical readiness following ACLR. In the proposed trial validated patient reported outcome measures will be used to assess for functional clinical improvement, while quadriceps musculature cross sectional area (CSA) as measured on MRI will be used to quantify the effect of therapy on quadriceps strength. The rationale for using this modality is based upon the fact that the measurement of quadriceps CSA and muscle volume as surrogates for overall quadriceps function is well described, and a number of studies have convincingly demonstrated positive correlations between these parameters and quadriceps strength4, 17. However, in spite of these reports, the acceptance acknowledging MRI as a surrogate for quadriceps strength remains limited. Therefore, isokinetic and isometric quadriceps strength of both the operative and non-operative knee extensors (quadriceps) will be measured pre-operatively within 7-10 days approximately prior to ACLR and post-operatively at approximately 12 weeks, 24 weeks, 36 weeks, and 52 weeks. MRI of bilateral thighs will be performed immediately prior to ACLR to establish a baseline CSA in the operative and non-operative lower extremity. Then a repeat MRI will be performed following the conclusion of a standardized 12-week (approximately) post-operative rehabilitation regimen among patients randomized to either a standard rehabilitation regimen (REHAB) or a rehabilitation regimen with BFR (REHAB + BFR.) Finally, MRI will be repeated at 52 weeks post-operative to examine for latent changes in CSA once patients have been returned to unrestricted physical activities.

AIM 1: To determine if the addition of BFR therapy to a standard post-operative rehabilitation protocol increases quadriceps muscle cross sectional area and volume after ACLR as measured with magnetic resonance imaging (MRI).

Hypothesis: The addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR will increase quadriceps muscle CSA and volume when compared to a standard post-operative rehabilitation regimen measured at approximately 12-weeks post-operative.

AIM 2: To determine if any observed increases in quadriceps muscle CSA and volume are sustained beyond the cessation of BFR therapy at approximately 12-weeks post-operative by performing repeat MRI at 52 weeks post-operative.

Hypothesis: Observed increases in quadriceps muscle CSA and volume will be sustained beyond the cessation of BFR therapy at 52 weeks post-operative.

AIM 3: To determine if CSA measurements obtained by MRI reliably predict knee extensor strength.

Hypothesis: CSA measurements obtained by MRI reliably predict knee extensor strength as measured by isokinetic and isometric testing.

AIM 4: To determine if the addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR results in significantly improved functional outcomes when compared to a standard post-operative rehabilitation regimen at 24, 36, and 52 weeks post-operative using patient reported outcomes (PRO).

Hypothesis: The addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR will result in significantly improved PRO when compared to a standard post-operative rehabilitation regimen at 24, 36, and 52-weeks post-operative.

Eligibility criteria: Inclusion Criteria:

* Active duty member or Department of Defense Military Health System beneficiary
* 15 to 45 years of age
* Indicated for ACL reconstruction with quadriceps tendon autograft with evidence of skeletal maturity; no open physes/growth plates

Exclusion Criteria:

* Patients undergoing a concomitant surgical procedure that would otherwise require a period of immobilization and/or restricted weight bearing (i.e. meniscal repair, meniscal allograft transplantation, osteochondral allograft transplantation, high tibial osteotomy) will be excluded.
* Undergoing combined multiligamentous knee injury reconstruction
* Unable to consistently participate in the prescribed post-operative rehabilitation regimen
* No patients with a history of recent lower extremity deep vein thrombosis, within the 12 months or on active treatment with anticoagulants, a history of ipsilateral lower extremity lymph node dissection or a history of endothelial dysfunction.
* Patients that are unable to obtain MRI secondary to either intolerance and/or implanted medical devices that preclude the safe completion of the MRI.

Primary outcomes:
measure: Quadriceps CSA MRI
timeFrame: [Timeframe: within 7-10 days of ACLR] [Time Frame: approximately 12-14 weeks post operative] [Time Frame: approximately 52-54 weeks post-operative]
measure: Knee extensor strength
timeFrame: [Time Frame: approximately withing 7-10 days of ACLR] [Time Frame: 12 weeks post operatively] [Time Frame: 24 weeks post-operatively] [Time Frame: 36 weeks post-operatively] [Time Frame: 52 weeks post-operatively]
Secondary outcomes:
measure: Patient Reported Outcome - Pain on 10 cm Visual Analog Scale (VAS)
timeFrame: [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]
measure: Patient Reported Outcome - Lyscholms Score
timeFrame: [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]
measure: Patient Reported Outcome - International Knee Documentation Committee Form (IKDC)
timeFrame: [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]
measure: Patient Reported Outcome - Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]
measure: Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) (Short version 6Q)
timeFrame: [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center- Clinical Research Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Andrew J Sheean, MD
role: PRINCIPAL_INVESTIGATOR
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