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

Sponsor

Children's Hospital Colorado (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04039971

Collaborator

(none)

150

Enrollment

Location

Arms

120

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear	Procedure: ACL Reconstruction	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 31, 2019

Anticipated Primary Completion Date :

Aug 31, 2029

Anticipated Study Completion Date :

Aug 31, 2029

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Reported Outcomes [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts 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