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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06194682
Other study ID # ACL(L2104)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 6, 2023
Est. completion date December 31, 2030

Study information

Verified date December 2023
Source Istituto Ortopedico Galeazzi
Contact Riccard D'Ambrosi, MD
Phone +393397066151
Email riccardo.dambrosi@hotmail.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Anterior cruciate ligament reconstruction
Anterior cruciate ligament arthroscopic reconstruction

Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

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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