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BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft

Sponsor
Brooke Army Medical Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT04519801
Collaborator
American Orthopaedic Society for Sports Medicine (Other)
86
Enrollment
2
Arms
17.9
Anticipated Duration (Months)

Study Details

Study Description

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 at 16 weeks and 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Flow Restriction (BFR) therapy
  • Other: Standard REHAB
 N/A

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 post-operatively at approximately 6 months and 9 months post operatively. 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 immediately following the conclusion of a standardized 16-week 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 16 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 16-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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme.Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme.
Masking:
Single (Investigator)
Masking Description:
The operating surgeon will remain blinded to the post-operative rehabilitation regimen to which subjects are randomized to post-operative rehabilitation regimen (REHAB vs. REHAB + BFR.)
Primary Purpose:
Treatment
Official Title:
Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: REHAB

Standard post-operative rehabilitation regimen (REHAB) (Control)

Other: Standard REHAB
Standard post-operative rehabilitation regimen (REHAB) beginning 1-week after ACL reconstruction with quadriceps tendon autograft.
Experimental: REHAB + BFR

Standard rehabilitation regimen with BFR therapy (REHAB + BFR) (Experimental)

Other: Blood Flow Restriction (BFR) therapy
BFR therapy beginning 1-week after ACL reconstruction with quadriceps tendon autograft.

Other: Standard REHAB
Standard post-operative rehabilitation regimen (REHAB) beginning 1-week after ACL reconstruction with quadriceps tendon autograft.

Outcome Measures

Primary Outcome Measures

  1. Quadriceps CSA MRI [7-10 days to 52-54 weeks post-operative]

    Quadriceps CSA as measured on MRI

  2. Knee extensor strength [6 to 9 months post-operative]

    Knee extensor isokinetic and isometric strength measurements

Secondary Outcome Measures

  1. Patient Reported Outcome - Pain on 10 cm Visual Analog Scale (VAS) [3, 6, and 12 months post-operative clinical follow-up appointments]

    The VAS is a unidimensional measure of pain intensity that has been frequently reported among adults. The simplest VAS is represented as a horizontal 10 cm line. The ends are defined as the extreme limits of parameter being measured (e.g. pain) oriented from the left (worst) to the right (best.) Patients are asked mark their perceived level of pain on the horizontal line. The VAS score is determined by measuring in mm from the left hand end of the horizontal line to where the patient marks. A higher score represents greater pain intensity.

  2. Patient Reported Outcome - Lyscholms Score [3, 6, and 12 months post-operative clinical follow-up appointments]

    Comprised of 8 items (limp, support, locking, instability, pain, swelling, stair climbing, squatting), which patients are asked a series of questions to characterize their experiences with respect to each of these 8 items. Patients' responses are summed, with a score of 100 denoting no symptoms or debility.

  3. Patient Reported Outcome - International Knee Documentation Committee Form (IKDC) [3, 6, and 12 months post-operative clinical follow-up appointments]

    This questionnaire is broken down into three categories: symptoms, sports activity, and knee function. The symptoms subscale focuses on an assessment of pain, stiffness, swelling, and the sensation of "giving-way" of the knee. The sports activity subscale focuses on completion of tasks such as going up and down stairs, rising from a seated position, squatting, and jumping. The knee function subscale asks the respondent to characterize their knee at present versus prior to injury. The IKDC is scored out of 100 points, with a score of 100 representing optimal knee function.

  4. Patient Reported Outcome - Knee Osteoarthritis Outcome Score (KOOS) [3, 6, and 12 months post-operative clinical follow-up appointments]

    The KOOS is a comprehensive scoring system that evaluates both short and long-term consequence of knee injury. It is comprised of 42 items, which are scored separately in 5 subscales (pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee-related quality of life (5 items).) Among the strengths of the KOOS as a PRO is its inclusion of two different subscales for physical function relating to daily life, sport, and recreation. A score of 100 represents no knee symptoms, which is then converted to a percentage score to characterize a patient's overall satisfaction with their knee function.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Active duty member or Department of Defense Military Health System beneficiary

  • 18 to 40 years of age

  • Indicated for ACL reconstruction with quadriceps tendon autograft.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brooke Army Medical Center
  • American Orthopaedic Society for Sports Medicine

Investigators

  • Principal Investigator: Andrew J Sheean, MD, Brooke Army Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Andrew Sheean, Director of Resident Research, Orthopaedic Sports Medicine, Principal Investigator, Staff Orthopaedic Surgeon, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT04519801
Other Study ID Numbers:
  • C.2020.053
First Posted:
Aug 20, 2020
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Andrew Sheean, Director of Resident Research, Orthopaedic Sports Medicine, Principal Investigator, Staff Orthopaedic Surgeon, Brooke Army Medical Center
BFR
ACLR
Quadriceps Tendon
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Feb 3, 2021