Clinical trial NCT02426996: The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation
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
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Did the patient return to activity at 3 months? yes/no
timeFrame: Week 6 after inclusion, which = 3 months after surgery
Secondary outcomes:
measure: Constant score
timeFrame: week -6
measure: Constant score
timeFrame: day 0 (study inclusion)
measure: Constant score
timeFrame: week 6
measure: Constant score
timeFrame: week 18
measure: Walch-Duplay score
timeFrame: week -6
measure: Walch-Duplay score
timeFrame: day 0 (study inclusion)
measure: Walch-Duplay score
timeFrame: week 6
measure: Walch-Duplay score
timeFrame: week 18
measure: Presence/absence of complications
timeFrame: day 0 (study inclusion)
measure: Presence/absence of complications
timeFrame: week 6
measure: Presence/absence of complications
timeFrame: week 18
measure: Visual analog scale for pain
timeFrame: day 0 (study inclusion)
measure: Visual analog scale for pain
timeFrame: week 6
measure: Visual analog scale for pain
timeFrame: week 18
measure: Date of return to total activity
timeFrame: week 18
measure: Visual analog scale for satisfaction
timeFrame: week 18
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: Clinique Saint Jean
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Olivier Marès, MD
role: PRINCIPAL_INVESTIGATOR
References: