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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 different types of low-dose x-ray exams, EOSedge and conventional DXA. The main question it aims to answer is:
Is there agreement between the calculated T-scores between the 2 different types of x-ray exams?
This is a multi-center, prospective, controlled, cross-sectional agreement study of subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging OR volunteers undergoing non-diagnostic 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 and DXA scans.
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.
DXA exams will be study-prescribed (or standard of care if consistent with this protocol) and ideally performed on the same day as EOSedge exams (but may be scheduled as much as 60 days apart).
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 DXA scan according to ISCD guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Other | Healthy volunteers will undergo EOSedge and DXA imaging |
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| Subjects indicated for EOSedge imaging | Other | Subject receiving EOSedge imaging as SOC will also receive an additional DXA scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DXA Imaging | Radiation | DXA imaging: lumbar spine, bi-lateral femoral necks |
|
| Measure | Description | Time Frame |
|---|---|---|
| AP Spine T-score Agreement | Calculation of EOSedge BMD 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. BMD results from the conventional DXA system will be similarly acquired from the spine (AP L1-L4) exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems. | between 0-60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hip T-score Agreement | Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the femoral neck in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the hip exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems. |
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Inclusion Criteria:
Observational Arm:
o Subjects at clinical sites, indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/or other orthopaedic conditions) as part of their routine medical care. Participants may already have completed their routine imagining, or may be scheduled to undergo it within 60 days of study enrollment.
Interventional Arm:
o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study.
Male or female subjects who are at least 20 years of age at the time of imaging acquisition
Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study
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 |
|---|---|---|---|---|---|---|
| Honor Health | Recruiting | Phoenix | Arizona | 85027 | United States |
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| EOSedge imaging | Radiation | Full body or full spine image |
|
| between 0-60 days |
| ATEC Carlsbad | Active, not recruiting | Carlsbad | California | 92008 | United States |
| ATEC Mephis | Active, not recruiting | Memphis | Tennessee | 38118 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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