An observational study in Osteoporosis, sponsored by St. Louis Joint Replacement Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by St. Louis Joint Replacement Institute · Observational
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:
The eligible patient population for this study will include all patients who require a noncontrast CT as a part of their clinical care. The effective number of cases included will depend on the availability and quality of calibrated CT-scan imaging data necessary to perform FEA as detailed in the selection criteria.
Subjects (males and/or females) must be ≥ 18 years of age
Exclusion Criteria:
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.
Primary Endpoint: Collection of calibrated CT scans to obtain human imaging data to perform a Finite Element Analysis (FEA) on a simulated surgery using a specific implant, as per clinical practice.
To perform the Finite Element Analysis (FEA), the following data will be requested: * Shoulder calibrated CT-scan * Date of calibrated CT-scan execution * Subject's year of birth * Subject's sex * Subject's weight * Subject's height * Subject's ethnicity
Time frame: <24 hours
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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St. Louis Joint Replacement Institute