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

NCT02426996 | Terminated

• 2 other identifiers: LOCAL/2014/OM-012015-A00155-44
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

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

  Week 6 after inclusion, which = 3 months after surgery

Secondary Outcomes (16)

• Constant score

  week -6

• Constant score

  day 0 (study inclusion)

• Constant score

  week 6

• Constant score

  week 18

• Walch-Duplay score

  week -6

Study Arms (1)

Study population

EXPERIMENTAL

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

Interventions

Scan of shoulder PROCEDURE

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.

Study population

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Clinique Saint Jean

Montpellier, 34093, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Olivier Marès, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 27, 2015
• Study Start: May 1, 2016
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: July 3, 2018

Record last verified: 2017-08

Locations

FR (2)