Evaluating ACL injury and re-rupture rates after surgery
"Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"
This study looks at how often people who had ACL surgery from 2020 to 2030 experience re-injury and how their recovery affects their ability to return to sports and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 370 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06194682 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the epidemiology and re-rupture rates of the anterior cruciate ligament (ACL) in patients who underwent ACL reconstruction surgery between 2020 and 2030. It will collect data both retrospectively and prospectively, focusing on clinical and radiographic outcomes. The primary outcome is the rate of ACL re-rupture, measured using the Lachmann test, while secondary objectives include identifying predisposing anatomical and demographic factors, as well as evaluating the rate of return to sports and quality of life post-surgery.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-65 who have undergone ACL reconstruction surgery at the specified hospital.
Not a fit: Patients with concomitant ligament injuries, neuropsychiatric conditions, or those who are pregnant or minors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the factors influencing ACL re-rupture rates, potentially leading to improved surgical techniques and rehabilitation protocols.
How similar studies have performed: Other studies have shown success in evaluating ACL injuries and outcomes, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- IRCCS Istituto Ortopedico Galeazzi — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Riccard D'Ambrosi, MD
- Email: riccardo.dambrosi@hotmail.it
- Phone: +393397066151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.