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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
KT-1000 Arthrometer
Secondary outcome measures
ACL Return to Sport Index (ACL-RSI)
International Knee Documentation Committee (IKDC) Knee Evaluation Form
Knee Injury and Osteoarthritis Outcome Score (KOOS)
+5 more

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
1,590 Previous Clinical Trials
2,281,254 Total Patients Enrolled
Amit Momaya, MDPrincipal InvestigatorDepartment of Orthopaedic Surgery, University of Alabama at Birmingham
2 Previous Clinical Trials
134 Total Patients Enrolled

Media Library

BTB (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05461326 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Quad tendon, BTB tendon
Anterior Cruciate Ligament Injury Clinical Trial 2023: BTB Highlights & Side Effects. Trial Name: NCT05461326 — N/A
BTB (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05461326 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial attempting to enroll new participants?

"This clinical trial is no longer actively recruiting, according to information available on the clinicialtrials.gov website; with its initial post dating back to January 1st 2023 and a recent update occurring October 22nd 2022. However, there are still 160 other trials that have open recruitment periods right now."

Answered by AI

Am I a viable candidate for participation in this trial?

"This clinical trial seeks to enrol 100 individuals between 15 and 40 years old who have experienced a tear of the anterior cruciate ligament. Applicants must also meet additional criteria, including being skeletally mature, exhibiting ACL insufficiency, and planning on undergoing autograft reconstruction surgery."

Answered by AI

Are elderly individuals aged 75+ eligible to join this research endeavor?

"According to the study's terms, applicants must be between 15 and 40 years old in order to gain access."

Answered by AI
~22 spots leftby Jun 2024