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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039971
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie Watson Mayer, MD, Children's Hospital Colorado

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear Procedure: ACL Reconstruction Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tendon-Bone Graft
Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.
Procedure: ACL Reconstruction
Surgical techniques

Active Comparator: All-Soft-Tissue Graft
Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.
Procedure: ACL Reconstruction
Surgical techniques




Primary Outcome Measures :
  1. 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.

  2. Long-Term Graft Superiority [ Time Frame: 5 years ]
    Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039971


Contacts
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Contact: Whitney Hovater, BS 720-777-8216 whitney.hovater@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Whitney Hovater, BS    720-777-8216    whitney.hovater@childrenscolorado.org   
Principal Investigator: Stephanie Mayer, MD         
Sponsors and Collaborators
Children's Hospital Colorado
Investigators
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Principal Investigator: Stephanie Mayer, MD Children's Hospital Colorado
Publications:

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Responsible Party: Stephanie Watson Mayer, MD, Assistant Professor, Orthopaedic Surgery, Children's Hospital Colorado
ClinicalTrials.gov Identifier: NCT04039971    
Other Study ID Numbers: 19-1445
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with individuals or organizations outside of the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Watson Mayer, MD, Children's Hospital Colorado:
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
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries