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The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two low-dose x-ray exams. The main question it aims to answer is:
What is the precision measurement between the BMD assessments from 2 x-ray exams?
This is a single-center, prospective, precision study of 30 subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging.
From the potential pool of EOSedge examinees, screening data will be reviewed to determine further eligibility. Subjects who sign an informed consent form and meet all inclusion criteria and none of the exclusion criteria will be asked to participate in the study.
Subjects who consent to participate will be enrolled from the time of consent through completion of evaluable image acquisition which will include both EOSedge exams.
EOSedge exams will be performed as is typical for the evaluation of spinal and/or other orthopaedic conditions, and the output will be collected for post-hoc computation of BMD.
The second EOS exam will be study prescribed and performed immediately after the first exam, with the operator repositioning the subject between acquisitions, i.e., removing the subject from the scanner and repositioning between exams.
In addition to the radiographic imaging from which spinal/postural alignment parameters may be obtained, some demographic and diagnostic details about the subject will be captured via study-specific case report forms (CRFs). Subjects will also complete a questionnaire that every subject fills out prior to having a bone mineral density scan according to ISCD guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects indicated for EOSedge imaging | Other | Subject receiving EOSedge imaging as SOC will also receive an additional EOSedge scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOSedge imaging | Radiation | Full body or full spine image |
|
| Measure | Description | Time Frame |
|---|---|---|
| AP Spine BMD Precision | Calculation of EOSedge BMD from the 2 exams will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass on four lumbar vertebrae (L1-L4) in the anteroposterior (AP) projection. Precision error will be calculated from the 2 exams. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Hip BMD Precision | Calculation of EOSedge BMD from the 2 exams will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the hip (femoral necks). Precision error will be calculated from the 2 exams. | 1 day |
| Lateral L2-L3 Precision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager, Clinical Studies | Contact | 858-603-3139 | vshainsky@atecspine.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoIndy | Recruiting | Fishers | Indiana | 46038 | United States |
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Calculation of EOSedge BMD from the 2 exams will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the spine (lateral L2-L3). Precision error will be calculated from the 2 exams. |
| 1 day |