Follow-up of Anterior Cruciate Ligament Reconstruction

August 28, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.

Study Type

Observational

Enrollment (Estimated)

200

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 Contact Backup

Study Locations

  • France
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint-Etienne
        • Principal Investigator:
          • Thomas NERI, MD
        • Sub-Investigator:
          • Rémi PHILIPPOT, MD PhD
        • Sub-Investigator:
          • Alban STORDEUR, resident

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction will be included.

Description

Inclusion Criteria:

  • Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Exclusion Criteria:

  • None

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction
Patients having undergone an ACL reconstruction will be included.
Other: datas collection
data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of Magnetic Resonance Imaging (MRI) results
Time Frame: Pre-operative and Month: 12
Collected in medical records
Pre-operative and Month: 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of operative report results
Time Frame: Month: 12
Collected in medical records
Month: 12
Analysis of consultation report
Time Frame: pre-operative and Months: 1,5 , 3, 6, 12
Collected in medical records
pre-operative and Months: 1,5 , 3, 6, 12
Analysis of isokinetic tests
Time Frame: Months: 9, 12
Collected in medical records
Months: 9, 12
Analysis of clinical surveys
Time Frame: pre-operative and Months: 3, 6, 12
Collected in medical records
pre-operative and Months: 3, 6, 12

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Thomas NERI, MD, CHU Saint-Etienne

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)

March 1, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN162021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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