Clinical trial NCT04039971: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2019-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Short-Term Graft Superiority
timeFrame: 1 to 2 years
measure: Long-Term Graft Superiority
timeFrame: 5 years
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments
measure: Time to Return to Sports Rates
timeFrame: As recorded in post-operative physical therapy visits (approx. 6 months to 1 year)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Stephanie Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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