Actively Recruiting
Precision Assessment of Bone Mineral Density (BMD) Measurement With EOSedge14 - BMD Precision Study
Led by Alphatec Spine, Inc. · Updated on 2025-02-17
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indicated for full-spine or whole-body radiography using EOSedge 2E biplanar imaging
- Male or female aged 20 years or older at the time of imaging
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Received contrast agents or radionuclides within 7 days before imaging
- Pregnant or planning pregnancy during the study period
- Body mass index (BMI) of 35 kg/m2 or higher
- Severe degenerative changes or fracture deformity in lumbar spine or bilateral femoral neck/trochanter
- Presence of implants, hardware, or foreign material in the measurement area
- Unable to maintain correct position or remain still during imaging
- Extra or missing lumbar vertebrae (not having 5 mobile lumbar segments)
- Participating in another clinical study that may interfere with this trial
- Any condition that compromises safety or data quality as determined by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo two EOSedge imaging scans to assess bone mineral density precision, with repositioning between scans.
1 visit (in-person) with two imaging sessions
Trial Site Locations
Total: 1 location
1
OrthoIndy
Fishers, Indiana, United States, 46038
Actively Recruiting
Research Team
S
Sr. Manager, Clinical Studies
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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