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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 4
- Primary Endpoint
- Did the patient return to activity at 3 months? yes/no
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
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)