Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
"Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"
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
| Status | Recruiting |
| Enrollment | 370 |
| Est. completion date | December 31, 2030 |
| Est. primary completion date | December 31, 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Istituto Ortopedico Galeazzi | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Ortopedico Galeazzi |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rerupture rate | rate of rerupture rare evaluated with anterior tibial translation | 10 years |
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