Anterior Cruciate Ligament Study

NCT ID: NCT06194682

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-06

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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Conditions

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ACL Injury ACL Anterior Cruciate Ligament Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Anterior cruciate ligament reconstruction

Anterior cruciate ligament arthroscopic reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Riccard D'Ambrosi, MD

Role: CONTACT

+393397066151

Facility Contacts

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Riccardo D'Ambrosi, MD

Role: primary

+393397066151

Other Identifiers

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ACL(L2104)

Identifier Type: -

Identifier Source: org_study_id

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