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Procedure

Fertilized ACL Technique for Anterior Cruciate Ligament Injury (FACL Trial)

N/A
Waitlist Available
Led By Chad Lavender, MD
Research Sponsored by Marshall University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until study completion, average of 1 year
Awards & highlights

FACL Trial Summary

This trial will compare outcomes of two different types of ACL reconstruction in young vs. old patients, with or without additional bone marrow/DBM and InternalBrace augmentation.

Eligible Conditions
  • Anterior Cruciate Ligament Injury
  • Arthroscopy
  • Anterior Cruciate Ligament Tear

FACL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until study completion, average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and until study completion, average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CT scan of operative knee
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Scores
Change in LYSHOLM KNEE QUESTIONNAIRE
+8 more

FACL Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 25 years and older- ACL recon with DBM, Internal braceExperimental Treatment1 Intervention
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 II: 24 years and younger- ACL recon with DBM, Internal braceExperimental Treatment1 Intervention
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 III: 25 years and older- Standard ACL reconstructionActive Control1 Intervention
Patients in this arm will be 25 years of age and over will receive an allograft All-Inside ACL reconstruction
Group IV: 24 years and younger- Standard ACL reconstructionActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

Marshall UniversityLead Sponsor
20 Previous Clinical Trials
4,102 Total Patients Enrolled
Arthrex, Inc.Industry Sponsor
44 Previous Clinical Trials
29,822 Total Patients Enrolled
Chad Lavender, MDPrincipal InvestigatorMarshall University

Media Library

ACL reconstruction with bone marrow, demineralized bone matrix, and internal brace augmentation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04178538 — N/A
Arthroscopy Research Study Groups: 24 years and younger- ACL recon with DBM, Internal brace, 25 years and older- ACL recon with DBM, Internal brace, 25 years and older- Standard ACL reconstruction, 24 years and younger- Standard ACL reconstruction
Arthroscopy Clinical Trial 2023: ACL reconstruction with bone marrow, demineralized bone matrix, and internal brace augmentation Highlights & Side Effects. Trial Name: NCT04178538 — N/A
ACL reconstruction with bone marrow, demineralized bone matrix, and internal brace augmentation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04178538 — N/A
~11 spots leftby May 2025
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