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NCT Number: NCT05461326

Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

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.

Recruiting

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

Location status: Recruiting

Location contact

Amit Momaya, MD

CONTACT

[email protected]

(205)-930-8339

Audria Wood, MPH

SUB_INVESTIGATOR

Elizabeth M Benson, MS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quad tendon

Procedure

quadriceps tendon autograft

BTB

Procedure

patellar tendon autograft

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. Re-rupture rate

    Time frame: 2 years

    Incidence of rerupture based on clinical and radiographic (MRI) evidence

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Momaya, MD

CONTACT

[email protected]

864-436-0621

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 18, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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