Actively Recruiting

Age: 18Years +
All Genders
ID07041242

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 Patients Under 30

Led by Stefano Zaffagnini · Updated on 2025-07-17

164

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the outcomes and complication rates of anterior cruciate ligament (ACL) reconstruction using the single-bundle "over-the-top" technique combined with lateral extra-articular tenodesis (LET) in patients over 50 years old, compared with a control group under 30 years old. ACL injuries are common in the knee and surgical reconstruction is widely performed in younger, active individuals. However, this study explores the effectiveness and safety of this surgical approach in older adults, a group with increasing functional demands and life expectancy. The surgical method studied involves reconstructing the ACL using the gracilis and semitendinosus tendons with the over-the-top technique, combined with LET, an additional step that may reduce failure rates and improve knee stability. All patients in the study have undergone this combined procedure, enabling a direct comparison between older and younger groups treated with the same technique. The study includes patients operated on between 2007 and 2023. Participants will be assessed over a period of at least two years following surgery. Researchers will monitor complications, knee function through scores such as the Lysholm Knee Score and KOOS, pain levels using a Visual Analog Scale, and activity levels with the Tegner Score. This comprehensive follow-up aims to evaluate safety, functional outcomes, and the potential benefits of the combined ACL + LET technique across different age groups.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients operated on between 2007 and 2023 who were over 50 years old at the time of surgery (study group) or under 30 years old (control group)
  • Patients who underwent ACL reconstruction using gracilis and semitendinosus tendons with the over-the-top plus lateral extra-articular tenodesis technique
  • Patients of both male and female sex
  • Patients who have provided consent to participate in the study
Not Eligible

You will not qualify if you...

  • Previous surgery on the same limb such as meniscectomy, prior ACL reconstruction, surgically treated fractures, osteotomies, or meniscal transplants
  • Concomitant surgery on the same limb like osteotomies or meniscal transplants
  • Surgical technique different from the over-the-top with lateral extra-articular tenodesis using autologous gracilis and semitendinosus tendons
  • Other ligament injuries requiring surgical treatment
  • Patients younger than 18 years or 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 2 years

Participants who have undergone anterior cruciate ligament reconstruction using the single-bundle "over-the-top" technique combined with lateral extra-articular tenodesis are observed for outcomes and complications.

Periodic assessments over 2 years

Trial Site Locations

Total: 1 location

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy, 40136

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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