Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial
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|ClinicalTrials.gov Identifier: NCT04039971|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear||Procedure: ACL Reconstruction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial|
|Estimated Study Start Date :||August 31, 2019|
|Estimated Primary Completion Date :||August 31, 2029|
|Estimated Study Completion Date :||August 31, 2029|
Active Comparator: Tendon-Bone Graft
Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.
Procedure: ACL Reconstruction
Active Comparator: All-Soft-Tissue Graft
Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.
Procedure: ACL Reconstruction
- Short-Term Graft Superiority [ Time Frame: 1 to 2 years ]Graft superiority will be evaluated by the time to return to sports and the length of return to sports.
- Long-Term Graft Superiority [ Time Frame: 5 years ]Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.
- Patient Reported Outcomes [ Time Frame: Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments ]Patients will complete a survey at specific time points to gauge knee function throughout treatment.
- Time to Return to Sports Rates [ Time Frame: As recorded in post-operative physical therapy visits (approx. 6 months to 1 year) ]Time to return to sports will be evaluated based on physical therapy milestones related to return to sports clearance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039971
|Contact: Whitney Hovater, BSemail@example.com|
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Contact: Whitney Hovater, BS 720-777-8216 firstname.lastname@example.org|
|Principal Investigator: Stephanie Mayer, MD|
|Principal Investigator:||Stephanie Mayer, MD||Children's Hospital Colorado|