Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-up of Anterior Cruciate Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04781920
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Rupture Other: datas collection

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of Anterior Cruciate Ligament Reconstruction
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Analysis of Magnetic Resonance Imaging (MRI) results [ Time Frame: Pre-operative and Month: 12 ]
    Collected in medical records


Secondary Outcome Measures :
  1. Analysis of operative report results [ Time Frame: Month: 12 ]
    Collected in medical records

  2. Analysis of consultation report [ Time Frame: pre-operative and Months: 1,5 , 3, 6, 12 ]
    Collected in medical records

  3. Analysis of isokinetic tests [ Time Frame: Months: 9, 12 ]
    Collected in medical records

  4. Analysis of clinical surveys [ Time Frame: pre-operative and Months: 3, 6, 12 ]
    Collected in medical records


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction will be included.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781920


Contacts
Layout table for location contacts
Contact: Thomas NERI, MD (0)477127849 ext +33 thomas.neri@chu-st-etienne.fr
Contact: Alban STORDEUR, resident (0)477127849 ext +33 alban.stordeur@gmail.com

Locations
Layout table for location information
France
Chu Saint-Etienne
Saint-Étienne, France
Principal Investigator: Thomas NERI, MD         
Sub-Investigator: Rémi PHILIPPOT, MD PhD         
Sub-Investigator: Alban STORDEUR, resident         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Thomas NERI, MD CHU SAINT-ETIENNE
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04781920    
Other Study ID Numbers: IRBN162021/CHUSTE
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Anterior Cruciate Ligament
reconstruction
Operative report
 Consultation report
Isokinetic tests
Clinical surveys
Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Wounds and Injuries