Recruiting

NCT Number: NCT06194682

Anterior Cruciate Ligament Study

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

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Key information

Conditions

ACL Injury ACL Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, 20100, Italy

Location status: Recruiting

Location contact

Riccardo D'Ambrosi, MD

CONTACT

[email protected]

+393397066151

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior cruciate ligament reconstruction

Procedure

Anterior cruciate ligament arthroscopic reconstruction

Primary outcomes

Rerupture rate

Time frame: 10 years

rate of rerupture rare evaluated with anterior tibial translation

Study contacts

Contact information is provided by the study sponsor or research team.

Riccard D'Ambrosi, MD

CONTACT

[email protected]

+393397066151

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2030
Study completion: 2030
First posted: Jan 8, 2024
Registry last updated: Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed