Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Orthopedic Disorder, Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Quad tendon
* Procedure: BTB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quad tendon<br>ACL graft harvested from the quadriceps tendon | Procedure: Quad tendon<br>* quadriceps tendon autograft<br>|
| Active Comparator: BTB tendon<br>ACL graft harvested from the patellar tendon | Procedure: BTB<br>* patellar tendon autograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment | 
| 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 | 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment | 
| Marx Activity Scale | 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) | 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) | 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 | 
| Re-rupture rate | Incidence of rerupture based on clinical and radiographic (MRI) evidence | 2 years | 
| Short Term Survey (SF-12) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadriceps tendon, bone tendon bone, autograft