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Quad Tendon vs BTB Graft for ACL Reconstruction
N/A
Recruiting
Led By Amit Momaya, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two methods of ACL reconstruction - a quad tendon graft with a bone plug, and a patellar tendon graft - to see which is more effective.
Who is the study for?
This trial is for skeletally mature individuals under 40 with an ACL injury who are scheduled for autograft reconstruction. It's not suitable for those unlikely to follow physical therapy, needing multiple ligament reconstructions, or wanting to return to sports within 6 months. Pregnant or nursing persons can't join.
What is being tested?
The study compares two types of knee surgery grafts: the quad tendon (all soft tissue) and the patellar tendon (with bone). This randomized controlled trial aims to determine which graft option is better for ACL reconstruction.
What are the potential side effects?
Potential side effects may include pain at the graft site, swelling, infection risk, stiffness in the knee joint, difficulty regaining full range of motion and strength in the affected leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
KT-1000 Arthrometer
Secondary study objectives
ACL Return to Sport Index (ACL-RSI)
International Knee Documentation Committee (IKDC) Knee Evaluation Form
Knee Injury and Osteoarthritis Outcome Score (KOOS)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Quad tendonActive Control1 Intervention
ACL graft harvested from the quadriceps tendon
Group II: BTB tendonActive Control1 Intervention
ACL graft harvested from the patellar tendon
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,275 Total Patients Enrolled
Amit Momaya, MDPrincipal InvestigatorDepartment of Orthopaedic Surgery, University of Alabama at Birmingham
3 Previous Clinical Trials
148 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery to repair multiple ligaments in my knee.I am a suitable candidate for a procedure using my own tissue for transplantation.I am under 65 and my bones have stopped growing.My ACL is not functioning properly.I am scheduled for ACL surgery using my own tissue.I am either younger than 14 or 65 years old or older.My doctors consider me unsuitable for a tissue transplant due to poor tissue quality.
Research Study Groups:
This trial has the following groups:- Group 1: Quad tendon
- Group 2: BTB tendon
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.