Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge™ Versus Traditional DXA - BMD Agreement Study
Alphatec Spine, Inc.
Summary
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?
Description
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…
Eligibility
- Age range
- 20+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. 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. 2. Interventional Arm: o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study. 3. Male or female subjects who ar…
Interventions
- RadiationDXA Imaging
DXA imaging: lumbar spine, bi-lateral femoral necks
- RadiationEOSedge imaging
Full body or full spine image
Locations (4)
- Honor HealthPhoenix, Arizona
- ATEC CarlsbadCarlsbad, California
- ATEC MephisMemphis, Tennessee
- University of VirginiaCharlottesville, Virginia