Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

NCT ID: NCT05461326

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2030-06-30

Brief Summary

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.

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.

Conditions

Orthopedic Disorder; Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Quad tendon

ACL graft harvested from the quadriceps tendon

Group Type: ACTIVE_COMPARATOR

Quad tendon

Intervention Type: PROCEDURE

quadriceps tendon autograft

BTB tendon

ACL graft harvested from the patellar tendon

Group Type: ACTIVE_COMPARATOR

BTB

Intervention Type: PROCEDURE

patellar tendon autograft

Interventions

Quad tendon

quadriceps tendon autograft

Intervention Type: PROCEDURE

BTB

patellar tendon autograft

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Amit Momaya

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Momaya, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedic Surgery, University of Alabama at Birmingham

Locations

UAB Hospital Highlands

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amit Momaya, MD

Role: CONTACT

amomaya@uabmc.edu

864-436-0621

Facility Contacts

Amit Momaya, MD

Role: primary

amomaya@uabmc.edu

(205)-930-8339

Other Identifiers

IRB-300009203

Identifier Type: -

Identifier Source: org_study_id