Follow-up of Anterior Cruciate Ligament Reconstruction | NCT04781920

Studies
Follow-up of Anterior Cruciate Ligament Reconstruction

NCT04781920

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Recruiting

Last Update Posted

Aug 29, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Anterior Cruciate Ligament Rupture

Interventions

datas collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Sep 2025Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2024

Last Update Posted Date

Aug 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction		Patients having undergone an ACL reconstruction will be included.	Other: datas collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
datas collection	Other	data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests	Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Analysis of operative report results	Collected in medical records	Month: 12
Analysis of consultation report	Collected in medical records

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas NERI, MD	Contact	(0)477127849	+33	thomas.neri@chu-st-etienne.fr
Alban STORDEUR, resident	Contact	(0)477127849	+33	alban.stordeur@gmail.com

Overall Officials

Name	Affiliation	Role
Thomas NERI, MD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Saint-Etienne	Recruiting	Saint-Etienne			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided