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RecruitingNCT04781920Updated Aug 29, 2024

Follow-up of Anterior Cruciate Ligament Reconstruction

An observational study in Anterior Cruciate Ligament Rupture, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.

Read the 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.

02

Conditions studied

  • Anterior Cruciate Ligament Rupture

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Keywords

  • Anterior Cruciate Ligament
  • reconstruction
  • Operative report
  • Consultation report
  • Isokinetic tests
  • Clinical surveys
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

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

    Patients having undergone an ACL reconstruction will be included.

    Other: datas collection

Interventions

  • Otherdatas collection

    data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests

05

What researchers measure

Primary outcomes

  1. Analysis of Magnetic Resonance Imaging (MRI) results

    Collected in medical records

    Time frame: Pre-operative and Month: 12

Secondary outcomes

  1. Analysis of operative report results

    Collected in medical records

    Time frame: Month: 12

  2. Analysis of consultation report

    Collected in medical records

    Time frame: pre-operative and Months: 1,5 , 3, 6, 12

  3. Analysis of isokinetic tests

    Collected in medical records

    Time frame: Months: 9, 12

  4. Analysis of clinical surveys

    Collected in medical records

    Time frame: pre-operative and Months: 3, 6, 12

06

Study locations

1 of 1 sites recruiting
  • Chu Saint-Etienne
    Saint-Étienne, France
    • Thomas NERI, MD · Principal investigator
    • Rémi PHILIPPOT, MD PhD · Sub investigator
    • Alban STORDEUR, resident · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04781920
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Mar 4, 2021
Start date
Mar 1, 2021
Primary completion
Sep 2025 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 29, 2024

Study contacts

Thomas NERI, MD
Contact
thomas.neri@chu-st-etienne.fr
(0)477127849 ext. +33
Alban STORDEUR, resident
Contact
alban.stordeur@gmail.com
(0)477127849 ext. +33
Thomas NERI, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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