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Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

ConditionsOrthopedic DisorderAnterior Cruciate Ligament Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorUniversity of Alabama at Birmingham

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Skeletally mature patients younger 65

ACL insufficiency

Scheduled to undergo autograft ACL reconstruction

Appropriate candidate for autograft harvest

Disqualifiers

<14 or 65>

Poor autograft candidate (poor tissue quality)

Multi ligamentous reconstruction (PCL, MCL, or PLC)

Pregnant or nursing

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quad tendon

    Procedure/Surgery

    quadriceps tendon autograft

  • BTB

    Procedure/Surgery

    patellar tendon autograft

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Quad tendonActive comparator 1 intervention
Group B: BTB tendonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

KT-1000 Arthrometer

Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)

Time frame
Operative Day, 9 Months Post-Operative Clinic Visit

Secondary outcomes

1

International Knee Documentation Committee (IKDC) Knee Evaluation Form

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.

Time frame
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
2

Knee Injury and Osteoarthritis Outcome Score (KOOS)

This survey evaluates short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis

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

Marx Activity Scale

This survey measures activity-related patient-reported outcome.

Time frame
6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
4

Single Assessment Numeric Evaluation (SANE)

A rating of the patient's current illness score.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov
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