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Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)

Recruitingn/aAges 18 Years - 50 YearsAllStefano Zaffagnini
NCT07049484 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The anterior cruciate ligament (ACL) is one of the main stabilizers of the knee joint, and its injury is among the most common soft tissue injuries of the knee. Several surgical reconstruction techniques are available, utilizing various tissues as a graft for the neo-ligament, including both autografts and allografts. The "Over-the-top single-bundle technique with gracilis and semitendinosus tendons combined with lateral extra-articular tenodesis (LET)" was developed in 1998 by Prof. Marcacci and Prof. Zaffagnini, and it is still the preferred method for ACL reconstruction at the Second Clinic of the Rizzoli Orthopaedic Institute. Cadaveric biomechanical studies have shown that combining LET with ACL reconstruction improves knee joint stability in both the anteroposterior and rotational planes. However, a recent in vivo study has challenged this hypothesis, showing that in patients und

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients undergoing isolated ACL reconstruction using gracilis and semitendinosus tendons with the over-the-top technique and LET. * Both male and female patients. * Patients who have given consent to participate in the study. * Age between 18 and 50 years at the time of surgery. Exclusion Criteria: * Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, displaced fractures). * Surgical technique different from Over-the-Top with LET using autologous gracilis and semitendinosus tendons. * Other concomitant ligament injuries requiring surgical treatment. * Patients undergoing additional procedures at the same time as ACL reconstruction and LET (e.g., concomitant osteotomy, meniscus transplant, cartilage procedure…). * Patients who did not provide informed consent.
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What it tests

  • Not listed
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Where

1 site
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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