Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT06611059
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Organization:
Study Overview
Official Title:
Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 (\<1 mm error, compared to \> 4 mm under visual control) and orientation (\< 3◦ error compared to \> 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 (\<1 mm error, compared to \> 4 mm under visual control) and orientation (\< 3◦ error compared to \> 7◦). In glenoids with more significant deformities, planning also showed superiority.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IIBSP-PSG-2023-107 | REGISTRY | Clinical Research Ethics Committee | View |