Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial

Study Overview
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Brief Summary
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In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.

Detailed Description
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It is well known that ACL injuries are among the most common sports and knee injuries. As a result, ACL reconstruction is at the forefront both in terms of research and development and advancements in technique. One focus of research is graft choice and the risks and benefits associated with each. There are multiple valid graft choices including bone-patellar tendon-bone, hamstring tendon, quadriceps tendon, quadriceps tendon-patellar bone, and allograft. Graft choice is often patient centered and based on both patient and surgeon considerations such as age, sex, activity level, surgeon preference and graft associated complications. The present study seeks to compare the intraoperative, immediate perioperative, intermediate and long-term outcomes between tendon-bone and all-soft-tissue quadriceps tendon autograft in ACL reconstruction in adolescent patients. The investigators will analyze data on operative time, cost, complications, recovery of strength and range of motion, return to sports rates, patient reported outcomes, and failure rates. With this proposal the investigators hope to determine if there is a superior graft technique in this population. Both graft types are validated in the literature separately as options for ACL reconstruction in this age group. There has been no clinical research comparing the two graft types, and therefore no consensus is made among surgeons on whether to use tendon-bone or all-soft-tissue when it comes to the QT autograft. A secondary aim of this study is to obtain patient reported outcomes throughout the post-operative period to determine if the patient experience is different between the two graft types. This data may be used in guiding a surgeon's decision on which type to use with their patients.

Official Title
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Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial

Conditions
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Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Procedure: ACL Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Patients ages 12 to 19 (inclusive) Patients undergoing primary ACL reconstruction Exclusion Criteria: Patients with an underlying neuromuscular diagnosis or neurological injury Patients with lower extremity fractures, dislocations, or multi-ligamentous injuries, which required surgery, concurrent with or occurring two years or less prior to primary ACL injury. Patients with an underlying systemic or musculoskeletal diagnosis

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tendon-Bone Graft<br>Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction. | Procedure: ACL Reconstruction<br>* Surgical techniques<br>|
| Active Comparator: All-Soft-Tissue Graft<br>Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction. | Procedure: ACL Reconstruction<br>* Surgical techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Term Graft Superiority | Graft superiority will be evaluated by the time to return to sports and the length of return to sports. | 1 to 2 years | 
| Long-Term Graft Superiority | Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes | Patients will complete a survey at specific time points to gauge knee function throughout treatment. | Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments | 
| Time to Return to Sports Rates | Time to return to sports will be evaluated based on physical therapy milestones related to return to sports clearance. | As recorded in post-operative physical therapy visits (approx. 6 months to 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, ACL Tear, ACL Injury, ACL Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament, ACL Repair, ACL Reconstruction, ACL Surgery, Anterior Cruciate Ligament Repair, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Surgery