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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Shoulder Dislocation

Treatments: Procedure: Scan of shoulder

Study type: Interventional

Funder types: Other

Identifiers

NCT02426996

LOCAL/2014/OM-01

2015-A00155-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Study population

Experimental group

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

Treatment:

Procedure: Scan of shoulder