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

Marshall University

Status: Unknown

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

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04178538

1455859

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

25 years and older- ACL recon with DBM, Internal brace

Experimental group

Description:

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

Treatment:

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

25 years and older- Standard ACL reconstruction

Active Comparator group

Description:

Patients in this arm will be 25 years of age and over will receive an allograft All-Inside ACL reconstruction

Treatment:

Procedure: Standard ACL reconstruction with all inside technique

24 years and younger- ACL recon with DBM, Internal brace

Experimental group

Description:

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

Treatment:

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

24 years and younger- Standard ACL reconstruction

Active Comparator group

Description:

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

Treatment:

Procedure: Standard ACL reconstruction with all inside technique