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

Shoulder Dislocation Clinical Trial

— IACE Scan  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02426996
• Other study ID #: LOCAL/2014/OM-01
• Secondary ID: 2015-A00155-44
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Saint Jean	Montpellier Cedex 5
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Did the patient return to activity at 3 months? yes/no		Week 6 after inclusion, which = 3 months after surgery
Secondary	Constant score		week -6
Secondary	Constant score		day 0 (study inclusion)
Secondary	Constant score		week 6
Secondary	Constant score		week 18
Secondary	Walch-Duplay score		week -6
Secondary	Walch-Duplay score		day 0 (study inclusion)
Secondary	Walch-Duplay score		week 6
Secondary	Walch-Duplay score		week 18
Secondary	Presence/absence of complications		day 0 (study inclusion)
Secondary	Presence/absence of complications		week 6
Secondary	Presence/absence of complications		week 18
Secondary	Visual analog scale for pain		day 0 (study inclusion)
Secondary	Visual analog scale for pain		week 6
Secondary	Visual analog scale for pain		week 18
Secondary	Date of return to total activity		week 18
Secondary	Visual analog scale for satisfaction		week 18