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Study to Compare Bone Mineral Density Measurements Using Two EOSedge Full-Body or Spine X-Ray Exams in Adults
Led by Alphatec Spine, Inc. · Updated on 2025-02-17
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a precision study to compare bone mineral density BMD measurements obtained from two low-dose x-ray exams using EOSedge biplanar full-body or full-spine imaging. The study aims to determine the measurement precision between the BMD assessments from these two exams. This single-center, prospective study involves 30 subjects who are indicated for radiography to evaluate spinal or other orthopedic conditions. Participants will undergo two EOSedge imaging exams during the study. The first exam is performed as part of their standard care, while the second exam is performed immediately afterward with repositioning between scans. The imaging outputs will be used for post-study calculations of BMD. Demographic and diagnostic information will be collected through case report forms, and subjects will complete a questionnaire based on international guidelines prior to the BMD scan. During the study, participants will be involved from consent through completion of both imaging exams. Researchers will review the precision of BMD measurements specifically for the spine and hip regions. Safety considerations include monitoring for any factors that may affect image quality or participant positioning. The study duration for each participant involves the imaging procedures on the same day, and data collected will inform the precision of BMD assessment using EOSedge technology.
CONDITIONS
Brief Title
Bone Mineral Density Precision Study
Research Team
S
Sr. Manager, Clinical Studies
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