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

NCT ID: NCT04178538

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2023-11-11

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.

Conditions

ACL Tear; ACL Injury; Arthroscopy; Anterior Cruciate Ligament Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation

Intervention Type: PROCEDURE

ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique

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

Group Type: ACTIVE_COMPARATOR

Standard ACL reconstruction with all inside technique

Intervention Type: PROCEDURE

Standard ACL reconstruction with all inside technique

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

Group Type: EXPERIMENTAL

ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation

Intervention Type: PROCEDURE

ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique

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

Group Type: ACTIVE_COMPARATOR

Standard ACL reconstruction with all inside technique

Intervention Type: PROCEDURE

Standard ACL reconstruction with all inside technique

Interventions

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

Intervention Type: PROCEDURE

Standard ACL reconstruction with all inside technique

Standard ACL reconstruction with all inside technique

Intervention Type: PROCEDURE

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.

Exclusion Criteria

• An understanding of the purpose of the study, and have signed the informed consent.
• Able to return for all subsequent study visits

• 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Marshall University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad Lavender, MD

Role: PRINCIPAL_INVESTIGATOR

Marshall University

Locations

Marshall University Department of Orthopedics

Huntington, West Virginia, United States

Countries

United States

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.

Reference Type: BACKGROUND

PMID: 23820260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26772611 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28224069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25384474 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28737949 (View on PubMed)

Other Identifiers

1455859

Identifier Type: -

Identifier Source: org_study_id