Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)
Launched by STEFANO ZAFFAGNINI · Jun 25, 2025
Trial Information
Current as of July 12, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a specific way to repair a torn anterior cruciate ligament (ACL), which is a key ligament that helps keep your knee stable. The surgery being studied combines the usual ACL reconstruction with an extra procedure called lateral extra-articular tenodesis (LET). This extra step is thought to improve knee stability, especially in the early months after surgery, but it’s not yet clear how long those benefits last or how much they help with certain types of knee movement. The goal of this study is to better understand how this combined surgery affects knee stability during the first year after the operation, so doctors and therapists can help patients recover more safely and decide when it’s best to return to sports or other activities.
People who might be eligible for this study are adults between 18 and 50 years old who need ACL reconstruction surgery using tendons from their own leg (specifically the gracilis and semitendinosus tendons) with the "over-the-top" surgical technique combined with LET. Patients who have had previous surgery on the same knee, other ligament injuries needing treatment, or additional knee procedures at the time of surgery won’t be eligible. If you join the study, you can expect close monitoring of your knee’s stability and function during the first year after surgery to see how well the combined procedure works. This information will help improve recovery plans and support better outcomes for future patients.
Gender
ALL
Eligibility criteria
- 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.
About Stefano Zaffagnini
Stefano Zaffagnini is a distinguished clinical trial sponsor known for his commitment to advancing medical research and enhancing patient care. With a strong background in orthopedic surgery and a focus on innovative treatments, he leads initiatives that explore cutting-edge methodologies in rehabilitation and sports medicine. His collaborative approach fosters partnerships with academic institutions and healthcare organizations, aiming to translate scientific findings into practical applications. Through rigorous trial design and ethical oversight, Zaffagnini strives to improve health outcomes and contribute to the body of knowledge in his field.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported