ACL reconstruction with lateral extra‑articular tenodesis (LET): clinical and biomechanical outcomes
Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET): a Short-term Prospective Arthrometric Study
This project will see if adding lateral extra‑articular tenodesis (LET) to ACL reconstruction changes knee stability and recovery in adults 18–50 who receive gracilis and semitendinosus grafts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT07049484 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–50 undergoing isolated primary ACL reconstruction with the over‑the‑top technique using autologous gracilis and semitendinosus tendons who give informed consent are ideal candidates.
Not a fit: Patients with prior surgery on the same limb, additional ligament injuries or other simultaneous knee procedures, those outside the 18–50 age range, or those having a different surgical technique are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, the findings could clarify whether adding LET provides better knee stability and lower re‑injury risk, helping surgeons choose the optimal reconstruction approach.
How similar studies have performed: Cadaveric biomechanical studies have generally shown improved anteroposterior and rotational stability with LET, but recent in vivo data are mixed and report primarily anteroposterior gains only.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: stefano zaffagnini
- Email: stefano.zaffagnini@unibo.it
- Phone: 0516366075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.