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Clinical Trials/NCT02426996
NCT02426996
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country3 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Dislocation
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
3
Locations
2
Primary Endpoint
Did the patient return to activity at 3 months? yes/no
Status
Terminated
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 4, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: Week 6 after inclusion, which = 3 months after surgery

Secondary Outcomes

  • Walch-Duplay score(week 18)
  • Constant score(week 18)
  • Date of return to total activity(week 18)
  • Presence/absence of complications(week 18)
  • Visual analog scale for pain(week 18)
  • Visual analog scale for satisfaction(week 18)

Study Sites (2)

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