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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACL Reconstruction
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring 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

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tendon-Bone Graft

All-Soft-Tissue Graft

Arm Description

Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.

Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.

Outcomes

Primary Outcome Measures

Short-Term Graft Superiority
Graft superiority will be evaluated by the time to return to sports and the length of return to sports.
Long-Term Graft Superiority
Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.

Secondary Outcome Measures

Patient Reported Outcomes
Patients will complete a survey at specific time points to gauge knee function throughout treatment.
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.

Full Information

First Posted
July 26, 2019
Last Updated
January 18, 2023
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT04039971
Brief Title
Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial
Official Title
Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 31, 2029 (Anticipated)
Study Completion Date
August 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tendon-Bone Graft
Arm Type
Active Comparator
Arm Description
Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.
Arm Title
All-Soft-Tissue Graft
Arm Type
Active Comparator
Arm Description
Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction
Intervention Description
Surgical techniques
Primary Outcome Measure Information:
Title
Short-Term Graft Superiority
Description
Graft superiority will be evaluated by the time to return to sports and the length of return to sports.
Time Frame
1 to 2 years
Title
Long-Term Graft Superiority
Description
Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes
Description
Patients will complete a survey at specific time points to gauge knee function throughout treatment.
Time Frame
Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments
Title
Time to Return to Sports Rates
Description
Time to return to sports will be evaluated based on physical therapy milestones related to return to sports clearance.
Time Frame
As recorded in post-operative physical therapy visits (approx. 6 months to 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Whitney Hovater, BS
Phone
720-777-8216
Email
whitney.hovater@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Mayer, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitney Hovater, BS
Phone
720-777-8216
Email
whitney.hovater@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Stephanie Mayer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with individuals or organizations outside of the research team.
Citations:
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Citation
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Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial

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