Clinical trial NCT04178538: The Effect of Fertilized ACL Technique on Outcomes of ACL Reconstruction in Young Adults
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Tear
ACL Injury
Arthroscopy
Anterior Cruciate Ligament Tear
Keywords: Anterior cruciate ligament tear
ACL
Lead sponsor: Marshall University
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2019-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in X rays
timeFrame: 6 months, 1 year, and 2 years
measure: Changes in International Knee Documentation score
timeFrame: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
measure: Changes in Visual analog pain scale
timeFrame: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
measure: Change in Knee Injury and Osteoarthritis Outcome (KOOS) Scores
timeFrame: 6 months, 1 and 2 years post-operatively
measure: Change in THE VETERANS RAND 12 ITEM HEALTH SURVEY
timeFrame: 6 months, 1 and 2 years post-operatively
measure: Change in LYSHOLM KNEE QUESTIONNAIRE
timeFrame: 6 months, 1 and 2 years post-operatively
measure: Change in MARX ACTIVITY SCALE FORM
timeFrame: 6 months, 1 and 2 years post-operatively
measure: Return to play
timeFrame: Until study completion, average of 1 year
measure: graft re-rupture rate
timeFrame: Until study completion, average of 1 year
measure: MRI
timeFrame: 12 weeks post op
measure: CT scan of operative knee
timeFrame: 6 months post op
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall University Department of Orthopedics
state: West Virginia
Study officials:
affiliation: Marshall University
name: Chad Lavender, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Narbona-Carceles J, Vaquero J, Suarez-Sancho S, Forriol F, Fernandez-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.
citation: 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.