Actively Recruiting
All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Led by University of Alabama at Birmingham · Updated on 2025-06-08
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two types of autografts used in anterior cruciate ligament (ACL) reconstruction surgery: the quadriceps tendon (QT) and the bone patellar tendon bone (BTB). The study focuses on patients needing ACL reconstruction and evaluates these graft choices through a randomized controlled trial. Both graft options are considered appropriate, but this trial will provide more direct comparison data, as previous studies have not compared all soft tissue QT to patellar tendon grafts in this way. Participants will be randomly assigned to receive either the BTB graft, which uses the middle third of the patellar tendon secured with a surgical button and screw, or the QT graft, which uses the quadriceps tendon fixed with surgical buttons at both ends. After enrollment, patients will be informed of their group and scheduled for surgery accordingly. Both procedures involve a single incision to harvest the graft. Following surgery, all participants will follow standard rehabilitation and attend scheduled postoperative visits at 2 weeks, 6 weeks, 3 months, 6 months, and 9 months, including routine x-rays at 2 weeks and 9 months. Throughout the study, participants will undergo assessments including KT-1000 arthrometer measurements on the day of surgery and at 9 months, along with various knee function and activity surveys at multiple time points up to 24 months. Pain levels will be tracked using a visual analog scale at several early and late postoperative timepoints. Researchers will monitor graft re-rupture rates over two years. The trial involves regular follow-ups and does not alter typical postoperative care except for a few additional measurements and surveys.
CONDITIONS
Brief Title
Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Skeletally mature patients younger than 65 years
- Diagnosed with anterior cruciate ligament (ACL) insufficiency
- Scheduled to undergo autograft ACL reconstruction surgery
- Considered appropriate candidates for autograft tissue harvest
You will not qualify if you...
- Younger than 14 years or older than 65 years
- Poor candidates for autograft due to poor tissue quality
- Needing multi-ligament reconstruction (PCL, MCL, or PLC)
- Pregnant or nursing
- High likelihood of not following physical therapy regimen
- Planning to return to sport before 6 months post-surgery
- Unable to read and write English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 1 day
Participants undergo ACL reconstruction surgery using either quadriceps tendon or patellar tendon autografts, followed by standard post-operative care.
1 surgery visit (in-person)
Duration - 9 months
Participants attend routine post-operative visits for rehabilitation and assessment including routine x-rays and KT-1000 measurements.
Post-operative visits at 2 weeks, 6 weeks, 3 months, 6 months, and 9 months with x-rays at 2 weeks and 9 months
Trial Site Locations
Total: 1 location
1
UAB Hospital Highlands
Birmingham, Alabama, United States, 35205
Actively Recruiting
Research Team
A
Amit Momaya, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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