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NCT04039971
Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial
Conditions: Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Sex: All
Ages: 12 Years – 19 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: University of Colorado, Denver
Location: Children's Hospital Colorado Aurora Colorado
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.
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
Source: ClinicalTrials.gov (NCT04039971). StuddyBuddy aggregates publicly available trial information.