Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611059
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-12-19
Brief Title:
Design of Patient Specific Guides PSG for Reverse Shoulder Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Design of Patient Specific Guides PSG for Reverse Shoulder Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSG
Brief Summary:
This is a two steps observational study
In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide As a secondary goal the problems detected during the design phase will be described
Once the accuracy of the guide is acceptable we will implant the glenosphere of future patients using the PSG guide following the same engineering design process
In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide As a secondary goal the problems detected during the design phase will be described
Once the accuracy of the guide is acceptable we will implant the glenosphere of future patients using the PSG guide following the same engineering design process
Detailed Description:
Reverse shoulder arthroplasty is a treatment for both non-synthesizable fractures and arthropathy degenerative This implant is based on two main components glenosphere and stem The stem in turn is integrated in its upper part by a polyethylene that reduces the friction torque between the glenosphere and the stem
Correct positioning of the glenosphere is critical for functionality and survival of the implant Malpositioning of glenosphere can be related to
In recent years given the
The scapula is a flat bone without any reference axis
Surgical approaches expose only the glenoid cavity with few bone landmarks
The humerus and deltoid make access to the glenoid difficult
The morphology of the scapula is very variable
Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid In glenoids with only a slight deformity PSGs improve the accuracy of the guide entry point ampampamplt1 mm error compared to ampampampgt 4 mm under visual control and orientation ampampamplt 3 error compared to ampampampgt 7 In glenoids with more significant deformities planning also showed superiority
Correct positioning of the glenosphere is critical for functionality and survival of the implant Malpositioning of glenosphere can be related to
In recent years given the
The scapula is a flat bone without any reference axis
Surgical approaches expose only the glenoid cavity with few bone landmarks
The humerus and deltoid make access to the glenoid difficult
The morphology of the scapula is very variable
Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid In glenoids with only a slight deformity PSGs improve the accuracy of the guide entry point ampampamplt1 mm error compared to ampampampgt 4 mm under visual control and orientation ampampamplt 3 error compared to ampampampgt 7 In glenoids with more significant deformities planning also showed superiority
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None