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

Not Applicable

Terminated

• Conditions: Shoulder Dislocation
• Interventions: Procedure: Scan of shoulder

• Registration Number: NCT02426996
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-27
• Study Start: 2016-05
• Primary Completion: 2017-05-04
• Study Completion: 2017-05-04
• Status Verified: 2017-08
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	Scan of shoulder	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

Primary Outcome Measures

Name	Time	Method
Did the patient return to activity at 3 months? yes/no	Week 6 after inclusion, which = 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Walch-Duplay score	week 18
Constant score	week 18
Date of return to total activity	week 18
Presence/absence of complications	week 18
Visual analog scale for pain	week 18
Visual analog scale for satisfaction	week 18

Trial Locations

Locations (2)

Clinique Saint Jean; 🇫🇷 Montpellier Cedex 5, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France