Preliminary Study of Feasibility of Arthrodesis Scapula-humeral Under Arthroscopy (DESEP)

Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility

Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.

Study Overview

• Status: Terminated
• Conditions: Arthroscopy Arthrodesis Gleno-humeral
• Intervention / Treatment: Procedure: arthroscopy arthrodesis of the shoulder

Detailed Description

This trial is about the arthrodesis shoulder blade/humerus under arthroscopy. The main aim of this study is to be able to carry out a fusion scapula-humeral supplements in 6 months. It is required to provide the benefice risk over to reduce the hospitalisation 48 hours.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Brest, Bretagne, France, 29200
      • Brest University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient having a deficit scapula-humeral mobility
• Impossibility of being operated for a preserving nervous surgery
• Patient affiliation with a social security
• Patient who signed inform consent

Exclusion Criteria:

• Patient with No mobility in all the articulations of the shoulder
• Callus malunion of the higher end of the humerus or the glen of the scapula
• Unable to sign an inform consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: shoulder arthroscopy arthrodesis; The shoulder surgery will be realized under arthroscopy only.	Procedure: arthroscopy arthrodesis of the shoulder; The shoulder surgery will be realized under arthroscopy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological fusion gleno humeral on side and front view after the 6th month of the arthroscopy interventional	This outcome will be considered like a success if the investigators get a continuous bone matrix between the humeral head and glenoid on the scapula and bone frame continues between the humeral head and the acromion. This evaluation will be done by radiographies.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	The blood loss during and after the surgery will be calculated and will be considered like a success if the total blood loss are less than 600ml.	3 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RB 12.172 DESEP