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

Primary Purpose

Shoulder Dislocation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scan of shoulder
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Dislocation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Saint Jean
  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study population

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2015
Last Updated
July 2, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02426996
Brief Title
The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruiting patients difficulties
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 4, 2017 (Actual)
Study Completion Date
May 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study population
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Scan of shoulder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Did the patient return to activity at 3 months? yes/no
Time Frame
Week 6 after inclusion, which = 3 months after surgery
Secondary Outcome Measure Information:
Title
Constant score
Time Frame
week -6
Title
Constant score
Time Frame
day 0 (study inclusion)
Title
Constant score
Time Frame
week 6
Title
Constant score
Time Frame
week 18
Title
Walch-Duplay score
Time Frame
week -6
Title
Walch-Duplay score
Time Frame
day 0 (study inclusion)
Title
Walch-Duplay score
Time Frame
week 6
Title
Walch-Duplay score
Time Frame
week 18
Title
Presence/absence of complications
Time Frame
day 0 (study inclusion)
Title
Presence/absence of complications
Time Frame
week 6
Title
Presence/absence of complications
Time Frame
week 18
Title
Visual analog scale for pain
Time Frame
day 0 (study inclusion)
Title
Visual analog scale for pain
Time Frame
week 6
Title
Visual analog scale for pain
Time Frame
week 18
Title
Date of return to total activity
Time Frame
week 18
Title
Visual analog scale for satisfaction
Time Frame
week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Marès, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Jean
City
Montpellier Cedex 5
ZIP/Postal Code
34093
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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