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

Treatment of Chronic Anterior Shoulder Instability by a Latarjet-type Bone Block Procedure Using the SEM (Science Et Medecine) Positioning Tool: Using a Scan to Assess Consolidation and Return to Normal Activity at 3 Months

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Scan of shoulder

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier Cedex 5, France, 34093
    • Clinique Saint Jean
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Constant score	week -6
Constant score	day 0 (study inclusion)
Constant score	week 6
Constant score	week 18
Walch-Duplay score	week -6
Walch-Duplay score	day 0 (study inclusion)
Walch-Duplay score	week 6
Walch-Duplay score	week 18
Presence/absence of complications	day 0 (study inclusion)
Presence/absence of complications	week 6
Presence/absence of complications	week 18
Visual analog scale for pain	day 0 (study inclusion)
Visual analog scale for pain	week 6
Visual analog scale for pain	week 18
Date of return to total activity	week 18
Visual analog scale for satisfaction	week 18

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 4, 2017
• Study Completion (Actual): May 4, 2017

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: LOCAL/2014/OM-01; 2015-A00155-44 (Other Identifier: RCB number)