The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation

NCT ID: NCT02426996

Last Updated: 2018-07-03

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

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-04

Brief Summary

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The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as conditioned by the quality of the bone block consolidation.

Detailed Description

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The secondary objectives of this study are to assess:

A. the position of the block according to a shoulder scan at 3 months post-surgery

B. functional scores (Constant, Walch-Duplay) at 6 weeks, 3 and 6 months post surgery.

C. Complications: osteoarthritis, lysis of the block.

D. pain.

E. date of return to full activity.

F. patient satisfaction concerning care (visual analog scale at 6 months post-surgery).

Conditions

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Shoulder Dislocation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study population

The patients included have been operated for chronic anterior shoulder instability by a Latarjet-type bone block procedure using the SEM (Science Et Medecine) positioning tool within the past 3 months.

Intervention: Scan of shoulder

Group Type EXPERIMENTAL

Scan of shoulder

Intervention Type PROCEDURE

A scan (no injection) of the concerned shoulder will be performed at 3 months post-surgery. Cuts in three planes of space, including all of the glenoid. 3D reconstructions.

Interventions

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Scan of shoulder

A scan (no injection) of the concerned shoulder will be performed at 3 months post-surgery. Cuts in three planes of space, including all of the glenoid. 3D reconstructions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient was operated for chronic anterior shoulder instability (defined by a history of at least two true dislocations and an ISIS score\> 2) 6 weeks ago (+/- 5 days)

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Marès, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Clinique Saint Jean

Montpellier, , France

Site Status

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00155-44

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/OM-01

Identifier Type: -

Identifier Source: org_study_id

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