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Recruiting NCT06194682

Anterior Cruciate Ligament Study

Observational ACL Injury ACL Anterior Cruciate Ligament Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anterior cruciate ligament reconstruction.
Who it may be relevant to
Registry conditions: ACL Injury, ACL, Anterior Cruciate Ligament Rupture. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

"Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"

Overview

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

Interventions

  • Procedure Anterior cruciate ligament reconstruction
    Anterior cruciate ligament arthroscopic reconstruction

Primary outcome measures

  • Rerupture rate [Time frame: 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Istituto Ortopedico Galeazzi — Milan

Identifiers

NCT: NCT06194682 · ACL(L2104)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗