NCT06611059

Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Proximal Humeral Fracture

Interventions

Type	Name	Description
DEVICE	PSG	Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2024-09-24
• Last updated: 2024-11-06

Locations

1 site across 1 country: Spain