Anterior Cruciate Ligament Study

December 22, 2023 updated by: Istituto Ortopedico Galeazzi

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy, 20100
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rerupture rate
Time Frame: 10 years
rate of rerupture rare evaluated with anterior tibial translation
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACL(L2104)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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