Anterior Cruciate Ligament Study

Recruiting

• Conditions: ACL Injury; Anterior Cruciate Ligament Rupture; ACL

• Registration Number: NCT06194682
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction.

The primary outcome is the rate of rupture of the anterior cruciate ligament as measured by the Lachmann test in which a positive value for re-rupture is an anterior translation of the tibia greater than 10mm relative to the femur Secondary Objectives: Verify predisposing factors to anterior cruciate ligament injuries (so anatomical factors such as tibial slope, trochlear groove), demographic factors (age, sex, weight, sports played), and the rate of return to sports, quality of life via questionnaires, and arthrosis at the operated knee

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-06
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• • Males and females- attained skeletal maturity
• 18-65 inclusive
• Patients operated on anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
• Signature informed consent for patients who will be operated on in the prospective phase (from CE approval date to 2030)

Exclusion Criteria

• failure to reach skeletal maturity

  • Concomitant ligamentous injuries (pcl, mcl, lcl)
  • Neuropsychiatric illness, developmental disorders
  • Pregnant women through self-declaration or breastfeeding
  • Minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rerupture rate	10 years	rate of rerupture rare evaluated with anterior tibial translation

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy