Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lima Corporation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| <24 hours |
Not provided
Not provided
Inclusion Criteria:
1. Subjects (males and/or females) must be ≥ 18 years of age
2. Subjects are willing and able to provide written informed consent for collection of the data; if a patient has already completed and performed the calibrated CT-scans as per standard clinical practice, the subject may be contacted to offer participation in the study.
3. Adult patients who will undergo noncontrast CT scanning of the shoulder as part of routine preoperative planning for shoulder arthroplasty will be eligible to participate in the study and receive a calibrated CT scan of the shoulder. The decision to undergo CT scan will be made independently of study participation; only patients who require a CT scan of the shoulder for clinically necessary reasons are eligible to participate.
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSM Health- DePaul | Bridgeton | Missouri | 63044 | United States |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |