Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Patient Reported Outcome - Pain on 10 cm Visual Analog Scale (VAS)([Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively])
• Connor-Davidson Resilience Scale (CD-RISC)([Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively])
• Patient Reported Outcome - Knee Osteoarthritis Outcome Score (KOOS)([Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively])
• Patient Reported Outcome - Lyscholms Score([Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively])
• Patient Reported Outcome - International Knee Documentation Committee Form (IKDC)([Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively])
• Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) (Short version 6Q)([Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively])