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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Treatments: Procedure: ACL Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04039971

19-1445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Tendon-Bone Graft

Active Comparator group

Description:

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

Treatment:

Procedure: ACL Reconstruction

All-Soft-Tissue Graft

Active Comparator group

Description:

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

Treatment:

Procedure: ACL Reconstruction