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

NCT04178538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-05

No results posted yet for this study

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.

Conditions

  • ACL Tear
  • ACL Injury
  • Arthroscopy
  • Anterior Cruciate Ligament Tear

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

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Marshall University

    lead OTHER

Principal Investigators

  • Chad Lavender, MD · Marshall University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-11-11
Completion
2023-11-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178538 on ClinicalTrials.gov