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

Status unconfirmed · Not applicable

Conditions studied: ACL Tear, ACL Injury, Arthroscopy, Anterior Cruciate Ligament Tear

In brief

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.

Key facts

Study ID

NCT04178538

Run by

Marshall University

People needed

60

Starts

2019-12-01

Expected to finish

2023-11-11

Last updated by the study team

2022-04-05

Who can join

Age: 14 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marshall University Department of Orthopedics — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.