Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
NCT Number: NCT06611059
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.
Looking for future studies?
Notify Me50 year–90 year
All sexes
Observational
Barcelona, 08025, Spain
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately
Other names: Patient Specific Guides
Time frame: 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
Time frame: 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).
Time frame: 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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
Acronym: PSG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05215613
Diaphyseal Fracture, Fractures, Bone
Bologna, Italy
View Trial DetailsNCT05960435
Fractures, Bone, Proximal Humeral Fracture
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06537024
Fractures, Bone, Proximal Humeral Fracture
View Trial DetailsNCT05735561
Avascular Necrosis, Avascular Necrosis of Humerus
New Westminster, British Columbia, Canada
View Trial Details