NCT05083728

S-32 PG 242 Short Stem

An Observational Study of Calibrated CT Scans to Evaluate Shoulder Geometry and Bone Density for Finite Element Analysis (FEA) on a Simulated Surgical Implant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: St. Louis Joint Replacement Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The data of calibrated CT-scans will be used for the Finite Element Analysis (FEA) analysis for SMR Short Stem in identified hospitals in EU and US as developers of the project and for further research, upon subject acceptance. In particular, the Quantitative Computer Tomography (QTC)/Finite Element Analysis (FEA) model of the assembly consisting of the shoulder and the orthopaedic implant allows detailed analyses including: * assessment of micromotion at the bone-implant interface, to predict osseointegration; * comparison of strains/stresses between the intact bone tissue and the bone with the implant in order to predict the stress shielding phenomenon.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT	Clinicians are free to choose the adult subjects in whom a non-contrast calibrated CT-scan will be performed as a part of routine clinical care. The decision to order a noncontrast CT-scan of the shoulder must be made prior to, and independently from, the decision to enroll the patient.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2021-10-19
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States