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

Centre Hospitalier Universitaire de Nīmes3 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Shoulder Dislocation

Interventions

Scan of shoulderPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

Clinique Saint Jean

Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Did the patient return to activity at 3 months? yes/no

Time frame: Week 6 after inclusion, which = 3 months after surgery

Secondary Outcomes

Constant score

Time frame: week -6

Constant score

Time frame: day 0 (study inclusion)

Constant score

Time frame: week 6

Constant score

Time frame: week 18

Walch-Duplay score

Time frame: week -6

Walch-Duplay score

Time frame: day 0 (study inclusion)

Walch-Duplay score

Time frame: week 6

Walch-Duplay score

Time frame: week 18

Presence/absence of complications

Time frame: day 0 (study inclusion)

Presence/absence of complications

Time frame: week 6

Presence/absence of complications

Time frame: week 18

Visual analog scale for pain

Time frame: day 0 (study inclusion)

Data from ClinicalTrials.gov

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