Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

NCT05461326 | Recruiting

• 1 other identifier: IRB-300009203
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder; Anterior Cruciate Ligament Injuries

Keywords

quadriceps tendon; bone tendon bone; autograft

Outcome Measures

Primary Outcomes (1)

• KT-1000 Arthrometer

  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 Outcomes (8)

• International Knee Documentation Committee (IKDC) Knee Evaluation Form

  6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment

• Marx Activity Scale

  6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment

• Single Assessment Numeric Evaluation (SANE)

  6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment

• Visual analog scale (VAS)

  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

Study Arms (2)

Quad tendon

ACTIVE COMPARATOR

ACL graft harvested from the quadriceps tendon

Procedure: Quad tendon

BTB tendon

ACTIVE COMPARATOR

ACL graft harvested from the patellar tendon

Procedure: BTB

Interventions

Quad tendon PROCEDURE

quadriceps tendon autograft

Quad tendon

BTB PROCEDURE

patellar tendon autograft

BTB tendon

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Amit Momaya, MD

  Department of Orthopaedic Surgery, University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Momaya, MD

CONTACT

864-436-0621; amomaya@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 18, 2022
• Study Start: September 26, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)