| NCT ID | NCT06194682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Condition | ACL Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 370 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 370 participants in total. It began in 2023-12-06 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06194682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06194682 currently recruiting?
Yes, NCT06194682 is actively recruiting participants. Contact the research team at riccardo.dambrosi@hotmail.it for enrollment information.
Where is the NCT06194682 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06194682 clinical trial?
NCT06194682 is sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. The trial plans to enroll 370 participants.