Proximal Humeral Fracture
Conditions
Keywords
reverse shoulder arthroplasty, patient specific guide, 3D
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.
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.
Interventions
DEVICEPSG
Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty * Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty
Exclusion criteria
* Previous surgeries on the proximal humerus or glenoid * No desire to participate in the study * Lack of ability to accept the study (tutored patients) * Open fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in glenoid center | months | Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn |
| Glenoid version deviation (α) | months | Glenoid version deviation (α): defined as the angle between the real trajectory of the drilling and the scapular anatomical plane, projected about the axis of neutral inclination (defined as that which goes from the center of the glenoid to the trigonum spinae). |
| Glenoid inclination deviation (β) | months | Glenoid inclination deviation (β): defined as the angle between the actual milling path and the plane of the neutral tilt axis, projected on the SP axis |
Countries
Spain
Outcome results
None listed