Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

June 4, 2025 updated by: Amit Momaya, University of Alabama at Birmingham

All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited from the PI's population base at Highlands Sports Medicine Clinic. Patients in need of an ACL reconstruction will be asked if they are interested in participating in a study comparing BTB and QT autografts by the PI (Dr. Amit Momaya). The benefits and risks of each graft choice will be thoroughly explained. Both graft options are considered equally appropriate management. Interested patients will be screened for eligibility criteria by a research assistant; those matching eligibility will be consented and enrolled in person at the time of the visit.

Patients will be randomized per trial arm assignment to either (i) assignment "0" or (ii) assignment "1". To ensure randomization, a random number generator is used to assign patient numbers and study groups; these assignments are placed with consent information to remain blinded to research personnel and participants until the consent and enrollment process. We anticipate fifty participants per assignment and oen-hundred participants in total. Assignment 0 represents the BTB group. This procedure harvests the patient's middle third of the patella tendon through a single incision for the new ACL graft. When the graft is in place, the graft is secured using a surgical button at the femoral end and a non-absorbable screw at the tibial end. Assignment 1 represents the QT group. This procedure harvests the patient's quadricep tendon through a single incision then utilizes surgical buttons to fix the graft at the tibial and femoral ends. Following enrollment, patients will immediately be notified of their assignment. Patients will also complete KT-1000 manual maximum side-to-side difference measurements . The patient will then be scheduled for ACL reconstruction surgery according to their assignment.

Following reconstruction, standard of care rehabilitation and mobility instructions will be provided. Participants are expected to complete the usual standard of care 2 week, 6 week, 3 month, 6 month, and 9 month postoperative appointments. At the 2 week and 9 month postoperative visits, a routine x-ray will be performed. Aside from a singular KT-1000 measurement and repeated surveys, the patient should not expect any differences in their postoperative visits compared to if they had not participated in the study.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • UAB Hospital Highlands
        • Sub-Investigator:
          • Elizabeth M Benson, MS
        • Sub-Investigator:
          • Audria Wood, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Skeletally mature patients younger 65
  • ACL insufficiency
  • Scheduled to undergo autograft ACL reconstruction
  • Appropriate candidate for autograft harvest

Exclusion Criteria:

  • <14 or 65>
  • Poor autograft candidate (poor tissue quality)
  • Multi ligamentous reconstruction (PCL, MCL, or PLC)
  • Pregnant or nursing
  • High likelihood of remaining non-compliant with physical therapy regimen
  • Desire to return to sport prior to 6 months
  • Inability to read and write English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quad tendon
ACL graft harvested from the quadriceps tendon
Procedure: Quad tendon
quadriceps tendon autograft
Active Comparator: BTB tendon
ACL graft harvested from the patellar tendon
Procedure: BTB
patellar tendon autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KT-1000 Arthrometer
Time Frame: Operative Day, 9 Months Post-Operative Clinic Visit
Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)
Operative Day, 9 Months Post-Operative Clinic Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-rupture rate
Time Frame: 2 years
Incidence of rerupture based on clinical and radiographic (MRI) evidence
2 years
International Knee Documentation Committee (IKDC) Knee Evaluation Form
Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
The International Knee Documentation Committee Subjective Knee Evaluation Form measures symptoms, function, and sports activity of people with a variety of knee disorders, including ligamentous and meniscal injuries, osteoarthritis, and patellofemoral dysfunction. Normative values have been published for comparison.
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
This survey evaluates short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Marx Activity Scale
Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
This survey measures activity-related patient-reported outcome.
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Single Assessment Numeric Evaluation (SANE)
Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
A rating of the patient's current illness score.
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Visual analog scale (VAS)
Time Frame: Post operative day 1, day 2, day 3, week 1, week 2, week 3, week 4, week 6, 3 months, 6 months, 9 months, 12 months, 24 months
pain rated on a 0-10 scale, 10 being worse
Post operative day 1, day 2, day 3, week 1, week 2, week 3, week 4, week 6, 3 months, 6 months, 9 months, 12 months, 24 months
Short Term Survey (SF-12)
Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
This survey reports the impact of health on a patient's everyday life.
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
ACL Return to Sport Index (ACL-RSI)
Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
A survey that evaluates patient's psychological readiness as it relates to return to sport.
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Amit Momaya, MD, Department of Orthopaedic Surgery, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300009203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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