Actively Recruiting

Phase Not Applicable
Age: 14Years - 65Years
All Genders
ID05461326

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

Age: 14Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Surgery and Immediate Post-operative Care

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)

Post-operative Follow-up

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

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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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