Evaluation After Reconstruction of the Anterior Cruciate... | NCT03529552

Studies
Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.

NCT03529552

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Terminated

Last Update Posted

Aug 5, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Rupture

Interventions

Anterior Cruciate Ligament Reconstruction

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

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The Dm production has been stopped

Expanded Access Info

Start Date

Sep 17, 2018Actual

Primary Completion Date

Apr 24, 2019Actual

Completion Date

Apr 24, 2019Actual

First Submitted Date

May 7, 2018

First Submission Date that Met QC Criteria

May 17, 2018

First Posted Date

May 18, 2018Actual

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 3, 2020

Last Update Posted Date

Aug 5, 2020Actual

Name	Class
Dedienne Sante S.A.S.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with anterior cruciate ligament rupture	Experimental		Procedure: Anterior Cruciate Ligament Reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anterior Cruciate Ligament Reconstruction	Procedure	Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)	Patients with anterior cruciate ligament rupture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In situ degradation of screw	Assessed on T1 and proton density fat saturation MRI	Year 3

Secondary Outcomes

Measure	Description	Time Frame
Knee stiffness	Articular amplitude test	Day -1
Knee stiffness	Articular amplitude test	Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient is at least 18 years old
The patient is available for at least 3 years of follow-up
The patient requires ligamentoplasty pour rupture of anterior cruciate ligament confirmed by MRI with or without meniscal lesions as scheduled surgery

Exclusion Criteria:

The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
The patient is pregnant or breast-feeding
The patient has a contra-indication (or a medically-incompatible association) for the treatment, including MRI
Revision surgery
Simultaneous surgery

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Marchand, MD	CHU Nimes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Polyclinique Urbain V		Avignon		84000	France
Centre Régina

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

ID	Term
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures