Clinical Trial: The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Norm
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 Summary:
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).
Sponsor: Centre Hospitalier Universitaire de Nīmes
Current Primary Outcome: Did the patient return to activity at 3 months? yes/no [ Time Frame: Week 6 after inclusion, which = 3 months after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Constant score [ Time Frame: week -6 ]
- Constant score [ Time Frame: day 0 (study inclusion) ]
- Constant score [ Time Frame: week 6 ]
- Constant score [ Time Frame: week 18 ]
- Walch-Duplay score [ Time Frame: week -6 ]
- Walch-Duplay score [ Time Frame: day 0 (study inclusion) ]
- Walch-Duplay score [ Time Frame: week 6 ]
- Walch-Duplay score [ Time Frame: week 18 ]
- Presence/absence of complications [ Time Frame: day 0 (study inclusion) ]
- Presence/absence of complications [ Time Frame: week 6 ]
- Presence/absence of complications [ Time Frame: week 18 ]
- Visual analog scale for pain [ Time Frame: day 0 (study inclusion) ]
- Visual analog scale for pain [ Time Frame: week 6 ]
- Visual analog scale for pain [ Time Frame: week 18 ]
- Date of return to total activity [ Time Frame: week 18 ]
- Visual analog scale for satisfaction [ Time Frame: week 18 ]
Original Secondary Outcome:
- Constant score [ Time Frame: week -6 ]
- Constant score [ Time Frame: day 0 (study inclusion) ]
- Constant score [ Time Frame: week 6 ]
- Constant score [ Time Frame: week 18 ]
- Rowe score [ Time Frame: week -6 ]
- Rowe score [ Time Frame: day 0 (study inclusion) ]
- Rowe score [ Time Frame: week 6 ]
- Rowe score [ Time Frame: week 18 ]
- ASES score [ Time Frame: week -6 ]
- ASES score [ Time Frame: day 0 (study inclusion) ]
- ASES score [ Time Frame: week 6 ]
- ASES score [ Time Frame: week 18 ]
- Walch-Duplay score [ Time Frame: week -6 ]
- Walch-Duplay score [ Time Frame: day 0 (study inclusion) ]
- Walch-Duplay score [ Time Frame: week 6 ]
- Walch-Duplay score [ Time Frame: week 18 ]
- Presence/absence of complications [ Time Frame: day 0 (study inclusion) ]
- Presence/absence of complications [ Time Frame: week 6 ]
- Presence/absence of complications [ Time Frame: week 18 ]
- Visual analog scale for pain [ Time Frame: day 0 (study inclusion) ]
- Visual analog scale for pain [ Time Frame: week 6 ]
- Visual analog scale for pain [ Time Frame: week 18 ]
- Date of return to total activity [ Time Frame: week 18 ]
- Visual analog scale for satisfaction [ Time Frame: week 18 ]
Information By: Centre Hospitalier Universitaire de Nīmes
Dates:
Date Received: April 15, 2015
Date Started: May 2016
Date Completion: February 2017
Last Updated: May 23, 2016
Last Verified: May 2016