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Search / Trial NCT07041242

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

Launched by STEFANO ZAFFAGNINI · Jun 19, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how well a specific knee surgery works for people over 50 compared to younger patients under 30. The surgery is for repairing a common knee injury called an anterior cruciate ligament (ACL) tear, which helps keep the knee stable. The surgery uses a special method called the "over-the-top" technique combined with an extra step called lateral extra-articular tenodesis (LET). This extra step has been shown to improve knee stability and reduce the chance of the repair failing, especially in younger patients. The study wants to see if older patients can expect similar good results and low complication rates when this combined surgery is done.

People who might be eligible for this study are those who had this specific ACL surgery between 2007 and 2023, either when they were over 50 or under 30 years old. Both men and women can join, but patients who had other surgeries on the same knee or who had different surgical techniques won’t be included. Participants will be followed for at least two years to track their recovery and any complications. This study is important because it helps doctors understand if this surgical approach is a safe and effective option for older adults who want to stay active and maintain good knee function.

Gender

ALL

Eligibility 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.

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.

Locations

Bologna, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported