NCT04781920

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2021Sep 2027

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

4.5 years

First QC Date

February 25, 2021

Last Update Submit

August 28, 2024

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior Cruciate LigamentreconstructionOperative reportConsultation reportIsokinetic testsClinical surveys

Outcome Measures

Primary Outcomes (1)

  • Analysis of Magnetic Resonance Imaging (MRI) results

    Collected in medical records

    Pre-operative and Month: 12

Secondary Outcomes (4)

  • Analysis of operative report results

    Month: 12

  • Analysis of consultation report

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

  • Analysis of isokinetic tests

    Months: 9, 12

  • Analysis of clinical surveys

    pre-operative and Months: 3, 6, 12

Study Arms (1)

Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Patients having undergone an ACL reconstruction will be included.

Other: datas collection

Interventions

datas collectionOTHER

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

Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Thomas NERI, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas NERI, MD

CONTACT

(0)477127849thomas.neri@chu-st-etienne.fr

Alban STORDEUR, resident

CONTACT

(0)477127849alban.stordeur@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 4, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)