ACL reconstruction with the over-the-top technique plus lateral extra-articular tenodesis in older versus younger patients
Official title: Outcomes and Complication Rates of Anterior Cruciate Ligament Reconstruction Using the "Over-the-top" Technique Combined With Lateral Extra-articular Tenodesis in Patients Over 50 Years Old, Compared With a Control Group of Patients Under 30
Run by Istituto Ortopedico Rizzoli · NCT07041242 · Data updated 2026-11-12
This project tests whether ACL reconstruction using the over-the-top technique combined with lateral extra-articular tenodesis gives similar outcomes and complication rates in people over 50 compared with people under 30.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | July 13, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07041242 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people who had ACL reconstruction with autologous gracilis and semitendinosus using the over-the-top plus LET technique, were operated on between 2007 and 2023, and were either over 50 or under 30 at the time of surgery with no prior or concurrent major knee surgeries.
✕Probably not a fit
Patients aged 30–50, minors, those who had other ligament surgeries or different surgical techniques, or who had prior major knee operations are not represented and likely will not benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective observational comparison of patients who underwent ACL reconstruction with autologous gracilis and semitendinosus tendons using the single-bundle over-the-top technique combined with lateral extra-articular tenodesis between 2007 and 2023. Patients are grouped by age at surgery (over 50 versus under 30) and outcomes and complication rates are compared. The study excludes patients with prior or concomitant major knee surgeries, other ligament injuries requiring surgical treatment, surgeries using different techniques, and patients aged 30–50 or under 18. Data are obtained from clinical records and follow-up visits at IRCCS Istituto Ortopedico Rizzoli in Bologna to compare functional outcomes and postoperative complications.
Why it matters
Potential benefit: If outcomes and complication rates are comparable, older patients may be offered this surgical approach more confidently to preserve knee function.
How similar studies have gone: Previous research indicates that adding LET to ACL reconstruction can reduce rotational instability and graft failure in younger or high-risk populations, but its specific performance in patients over 50 has been less studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients operated on between 2007 and 2023 who were over 50 years old at the time of surgery (study group) and patients under 30 years old at the time of surgery (control group). * Patients who underwent ACL reconstruction using the gracilis and semitendinosus tendons with the over-the-top + LET technique. * Patients of both male and female sex. * Patients who have provided consent to participate in the study. Exclusion Criteria: * Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, surgically treated fractures, osteotomies, meniscal transplants). * Concomitant surgery on the same limb (osteotomies, meniscal transplants). * Surgical technique different from the over-the-top with LET using autologous gracilis and semitendinosus tendons. * Other concomitant ligament injuries requiring surgical treatment. * Patients younger than 18 years at the time of surgery (minors) or patients aged between 30 and 50 years at the time of surgery. * Patients who have not provided informed consent. * Patients with a follow-up period shorter than 2 years.
Where it's running
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IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.