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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02426996
Acronym
IACE Scan
Enrollment
3
Registered
2015-04-27
Start date
2016-05-31
Completion date
2017-05-04
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

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).

Interventions

PROCEDUREScan 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Did the patient return to activity at 3 months? yes/noWeek 6 after inclusion, which = 3 months after surgery

Secondary

MeasureTime frame
Walch-Duplay scoreweek -6
Presence/absence of complicationsday 0 (study inclusion)
Constant scoreweek -6
Date of return to total activityweek 18
Visual analog scale for satisfactionweek 18
Visual analog scale for painday 0 (study inclusion)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026