The Effect of Fertilized ACL Technique on Outcomes of ACL Reconstruction in Young Adults

Overview

A prospective study, with outcomes including re-rupture rate and return to sport will be collected following ACL reconstruction. In keeping with the surgeon's standard practice, patients 24 years and under that are skeletally mature, will receive a quad tendon autograft; patients 25 years of age and over will receive an allograft All-Inside ACL reconstruction. These two cohorts will then be randomized into two groups, one with bone marrow/DBM and InternalBrace augmentation, and one without. The study procedures will involve use of x-rays, MRI, CT scan, and surveys at varying time points to assess radiographic, imaging and clinical outcomes.

Full Title of Study: “The Effect of Bone Marrow Aspirate, Demineralized Bone Matrix, and InternalBrace™ on the Outcomes of Anterior Cruciate Ligament Reconstruction in Young Adults; Failure Rates and Return to Play”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 11, 2020

Detailed Description

Graft re-rupture is one of the major complications and causes of reoperation after anterior cruciate ligament (ACL) reconstruction. This is more common in younger athletes. Based on the recent literature the rate of graft re-rupture is about 6-11%. Even with newer techniques and different types of grafts the re-rupture rates and return to play have not improved significantly. Athletes younger than 25 years old have been found to have a 23% risk of secondary ACL injury either on the contralateral or ipsilateral side after an ACL reconstruction. Therefore, there is a direct need to improve the outcomes of ACL reconstruction especially in younger athletes. This could be accomplished with earlier biologic incorporation of the graft and further protecting the graft during the early postoperative period. Quad tendon all-inside reconstruction is a reproducible technique for younger athletes receiving surgery. For patients over the age of 22, allograft is commonly used. Recently autogenous bone marrow aspirate has shown superior radiographic incorporation when used for osteochondral allograft transplantation in the knee. The bone marrow aspirate has also shown the presence of similar mesenchymal stem cell concentrations when harvested from the proximal tibia compared to when harvested from the iliac crest; providing a useful and safe alternative during knee surgery. This bone marrow aspirate can be combined with demineralized bone matrix (DBM) as a medium for incorporation into a femoral and tibial tunnel during reconstruction of an ACL. Recently, as an augment to the procedure, an ultrahigh-molecular-weight polyethylene/polyester suture tape was used as an InternalBrace for an ACL allograft reconstruction and found to be safe and effective. The hypothesis of this study is that the combination of the InternalBrace and biologic addition of autogenous bone marrow aspirate may provide improved functional outcomes, and reduced failure rates after ACL reconstruction.

Interventions

  • Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation
    • ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique
  • Procedure: Standard ACL reconstruction with all inside technique
    • Standard ACL reconstruction with all inside technique

Arms, Groups and Cohorts

  • Experimental: 25 years and older- ACL recon with DBM, Internal brace
    • Patients in this arm will be 25 years of age and over and receive ACL reconstruction augmented with demineralized bone matrix, bone marrow, and internal brace
  • Active Comparator: 25 years and older- Standard ACL reconstruction
    • Patients in this arm will be 25 years of age and over will receive an allograft All-Inside ACL reconstruction
  • Experimental: 24 years and younger- ACL recon with DBM, Internal brace
    • In this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft augmented with demineralized bone matrix, bone marrow, and internal brace
  • Active Comparator: 24 years and younger- Standard ACL reconstruction
    • In this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft standard all inside technique

Clinical Trial Outcome Measures

Primary Measures

  • Changes in X rays
    • Time Frame: 6 months, 1 year, and 2 years
    • AP and lateral radiographs of all patients included in the study will be obtained and assessed for changes over the study duration at specified time periods
  • Changes in International Knee Documentation score
    • Time Frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
    • Measures 3 categories: symptoms, sports activity, and knee function with a sum total 0-100 with 100 score having highest functional state and 0 low functioning.
  • Changes in Visual analog pain scale
    • Time Frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
    • High score 10 means high pain, low score 1 means low pain
  • Change in Knee Injury and Osteoarthritis Outcome (KOOS) Scores
    • Time Frame: 6 months, 1 and 2 years post-operatively
    • five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
  • Change in THE VETERANS RAND 12 ITEM HEALTH SURVEY
    • Time Frame: 6 months, 1 and 2 years post-operatively
    • patient-reported global health measure that is used to assess a patient’s overall perspective of their health. seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents physical and psychological health status. results of the VR-12 are summarized as two scores – a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points.
  • Change in LYSHOLM KNEE QUESTIONNAIRE
    • Time Frame: 6 months, 1 and 2 years post-operatively
    • patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
  • Change in MARX ACTIVITY SCALE FORM
    • Time Frame: 6 months, 1 and 2 years post-operatively
    • MARX focuses on four activity points: running, deceleration, cutting (changing directions while running), and pivoting. Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation.
  • Return to play
    • Time Frame: Until study completion, average of 1 year
    • We will assess the time it takes from date of ACl reconstruction until the patient returs to sporting activiy
  • graft re-rupture rate
    • Time Frame: Until study completion, average of 1 year
    • We will assess patients for incidence of graft rerupture rate during rehab or after return to play
  • MRI
    • Time Frame: 12 weeks post op
    • MIR scans will be performed first 6 patients in each group will receive MRIs of the knee to visualize graft maturation.
  • CT scan of operative knee
    • Time Frame: 6 months post op
    • At six (6) months, the first 6 patients in each group will receive CT scans of the knee to assess tunnel widening

Participating in This Clinical Trial

Inclusion Criteria

  • Patients must be age 14-60 years old.
  • Must be skeletally mature (Tanner 4) patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft or allograft augmentation.
  • Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, (and such pathology and treatment will be recorded).
  • An understanding of the purpose of the study, and have signed the informed consent.
  • Able to return for all subsequent study visits

Exclusion Criteria

  • Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
  • Patients whom have had previous ACL reconstructive surgery on ipsilateral knee.
  • Patients who are currently pregnant or nursing.
  • Patients who have a current infection at the operative site.
  • Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
  • Workmen's compensation cases

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Marshall University
  • Collaborator
    • Arthrex, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chad Lavender, MD, Principal Investigator, Marshall University
  • Overall Contact(s)
    • Chad Lavender, MD, 304-691-6710, Doclav@gmail.com

References

Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29. Review.

Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15. Review.

Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.

Narbona-Carceles J, Vaquero J, Suárez-Sancho S, Forriol F, Fernández-Santos ME. Bone marrow mesenchymal stem cell aspirates from alternative sources: is the knee as good as the iliac crest? Injury. 2014 Oct;45 Suppl 4:S42-7. doi: 10.1016/S0020-1383(14)70009-9.

Oladeji LO, Stannard JP, Cook CR, Kfuri M, Crist BD, Smith MJ, Cook JL. Effects of Autogenous Bone Marrow Aspirate Concentrate on Radiographic Integration of Femoral Condylar Osteochondral Allografts. Am J Sports Med. 2017 Oct;45(12):2797-2803. doi: 10.1177/0363546517715725. Epub 2017 Jul 24.

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