Active — Not RecruitingNot Applicable

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

United States150 participantsStarted 2020-08-01

Plain-language 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.

Who can participate

Age range12 Years – 19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Short-Term Graft Superiority

Timeframe: 1 to 2 years

Long-Term Graft Superiority

Timeframe: 5 years

Trial details

NCT IDNCT04039971

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-08-31

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injuries trials