Anterior Cruciate Ligament Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
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
This trial does not accept healthy volunteersQualifiers
- 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)
Disqualifiers
failure to reach skeletal maturity
Concomitant ligamentous injuries (pcl, mcl, lcl)
Neuropsychiatric illness, developmental disorders
Pregnant women through self-declaration or breastfeeding
Trial population
Patients who have undergone and will undergo anterior cruciate ligament reconstruction surgery at the CASCO Team between January 2020 and December 2030. Clinical data, any questionnaires, scores, and radiographic parameters were collected at the same time as the visits and prescribed procedures according to the clinical routine of the department. No additional services will be prescribed by virtue of participation in this study
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Anterior cruciate ligament reconstruction
Procedure/SurgeryAnterior cruciate ligament arthroscopic reconstruction
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rerupture rate
rate of rerupture rare evaluated with anterior tibial translation
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov