Anterior Cruciate Ligament Study
Recruiting now
Conditions studied: ACL Injury, ACL, Anterior Cruciate Ligament Rupture
In brief
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
Key facts
- Study ID
- NCT06194682
- Run by
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- People needed
- 370
- Starts
- 2023-12-06
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2024-01-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- - 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)
You may not qualify if…
- failure to reach skeletal maturity
- Concomitant ligamentous injuries (pcl, mcl, lcl)
- Neuropsychiatric illness, developmental disorders
- Pregnant women through self-declaration or breastfeeding
- Minors
Where it is running
- IRCCS Istituto Ortopedico Galeazzi — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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