ACL reconstruction with lateral extra‑articular tenodesis (LET): clinical and biomechanical outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study at the Rizzoli Orthopaedic Institute following adults who undergo ACL reconstruction using the over‑the‑top single‑bundle technique with gracilis and semitendinosus tendons combined with LET. Clinical outcomes and biomechanical measures of knee stability will be collected after surgery to describe results in routine practice. The protocol focuses on isolated primary ACL reconstructions without other concomitant ligament repairs or additional procedures. The work is motivated by cadaveric data supporting a stabilizing effect of LET and mixed in vivo findings that warrant further clinical characterization.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: stefano zaffagnini
• Email: stefano.zaffagnini@unibo.it
• Phone: 0516366075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.