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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ until study completion, average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until study completion, average of 1 year
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 moreFACL 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery to repair or reconstruct multiple ligaments in your body (such as MCL, PCL, LCL, PMC, or PLC).You have had a previous surgery to repair your ACL (a ligament in the knee) on the same side as the current study.Patients who have problems with their meniscus or cartilage can still participate in the study. If needed, these problems will be treated during the ACL reconstruction surgery, and the details of the treatment will be recorded.
Research Study Groups:
This trial has the following groups:- Group 1: 24 years and younger- ACL recon with DBM, Internal brace
- Group 2: 25 years and older- ACL recon with DBM, Internal brace
- Group 3: 25 years and older- Standard ACL reconstruction
- Group 4: 24 years and younger- Standard ACL reconstruction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research accept participants of a certain age or older?
"The eligibility requirements for this research necessitate that the participants are between 14 to 60 years of age. 47 studies are available for those younger than 18, while 30 studies apply to people over 65."
Answered by AI
Are there still opportunities to participate in this research endeavor?
"According to clinicaltrials.gov, this investigation has ceased its recruitment at present; the initial post was on December 1st 2019 and it underwent a review as recently as April 4th 2022. Despite this inactivity, there are currently 107 other trials actively recruiting patients."
Answered by AI
Do I meet the requirements to participate in this medical research endeavor?
"Eligibility requirements for this research stipulate that patients must have arthroscopy and be between the ages of 14 and 60. Approximately 60 individuals will be admitted to the clinical trial."
Answered by AI
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