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.

NCT ID: NCT03529552

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2019-04-24

Brief Summary

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The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with anterior cruciate ligament rupture

Group Type EXPERIMENTAL

Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

Interventions

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Anterior Cruciate Ligament Reconstruction

Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dedienne Sante S.A.S.

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Marchand, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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Polyclinique Urbain V

Avignon, , France

Site Status

Centre Régina

Nice, , France

Site Status

CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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IDIL/2017/PM-01

Identifier Type: -

Identifier Source: org_study_id

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