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Clinical Trials/NCT06194682
NCT06194682
Recruiting
N/A

"Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country370 target enrollmentDecember 6, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
ACL Injury
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
370
Locations
1
Primary Endpoint
Rerupture rate
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 6, 2023
End Date
December 31, 2030
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Rerupture rate

Time Frame: 10 years

rate of rerupture rare evaluated with anterior tibial translation

Study Sites (1)

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