Anterior Cruciate Ligament Study

NCT06194682 · tracked via the Priya Life Science Italy tracker

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Phase

Observational

Started

2023-12-06

Last updated

2024-01-08

Condition(s) studied

ACL InjuryACLAnterior Cruciate Ligament Rupture

Investigational drug(s) / intervention(s)

Anterior cruciate ligament reconstruction

Anterior cruciate ligament reconstruction: Anterior cruciate ligament arthroscopic reconstruction

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Rerupture rate — 10 years
rate of rerupture rare evaluated with anterior tibial translation

Trial sites (1)

Facility	City	Region	Status
IRCCS Istituto Ortopedico Galeazzi	Milan	Italy	Recruiting

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Other trials for the same condition

ACL Reconstruction with a New Generation of LARS Artificial Ligament Active, not recruiting

ACL Reconstruction in Patients Aged 50 Years and Older Active, not recruiting

Outcomes and Complication Rates of Anterior Cruciate Ligament Reconstruction Using the "Over-the-top" Technique Combined With Lateral Extra-articular Tenodesis in Patients Over 50 Years Old, Compared With a Control Group of Patients Under 30 Recruiting

Study of Functional Magnetic Resonance Signal Variations in Patients Undergoing Anterior Cruciate Ligament Reconstruction With the Application of a Dedicated Neuromotor Training Recruiting

Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06194682 on ClinicalTrials.gov ↗ ← All trials in Italy