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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426996
Recruitment Status : Terminated (Recruiting patients difficulties)
First Posted : April 27, 2015
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Shoulder Dislocation Procedure: Scan of shoulder Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : May 2016
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 4, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Did the patient return to activity at 3 months? yes/no [ Time Frame: Week 6 after inclusion, which = 3 months after surgery ]

Secondary Outcome Measures :
  1. Constant score [ Time Frame: week -6 ]
  2. Constant score [ Time Frame: day 0 (study inclusion) ]
  3. Constant score [ Time Frame: week 6 ]
  4. Constant score [ Time Frame: week 18 ]
  5. Walch-Duplay score [ Time Frame: week -6 ]
  6. Walch-Duplay score [ Time Frame: day 0 (study inclusion) ]
  7. Walch-Duplay score [ Time Frame: week 6 ]
  8. Walch-Duplay score [ Time Frame: week 18 ]
  9. Presence/absence of complications [ Time Frame: day 0 (study inclusion) ]
  10. Presence/absence of complications [ Time Frame: week 6 ]
  11. Presence/absence of complications [ Time Frame: week 18 ]
  12. Visual analog scale for pain [ Time Frame: day 0 (study inclusion) ]
  13. Visual analog scale for pain [ Time Frame: week 6 ]
  14. Visual analog scale for pain [ Time Frame: week 18 ]
  15. Date of return to total activity [ Time Frame: week 18 ]
  16. Visual analog scale for satisfaction [ Time Frame: week 18 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426996


Locations
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France
Clinique Saint Jean
Montpellier Cedex 5, France, 34093
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Olivier Marès, MD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02426996    
Other Study ID Numbers: LOCAL/2014/OM-01
2015-A00155-44 ( Other Identifier: RCB number )
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Shoulder Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries