EOSedge Imaging for Bone Mineral Density Comparison
Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
Recruiting
N/AInterventional Study
HealthyIndicated for EOSedge Imaging
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
214 (estimated)
Sponsor
Alphatec Spine, Inc. · Industry
Who this trial is looking for
This trial is looking for healthy adults who need an EOSedge imaging for spine or body evaluation. Participants will help compare bone mineral density measurements from different types of x-ray exams.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 20 years old.
I need an EOSedge imaging as part of my medical care.
I can provide written consent to participate.
I am scheduled for imaging within 60 days.
You may not be able to join if
I had a contrast agent or radionuclide within the last week.
I am pregnant or planning to become pregnant during the trial.
I have a BMI of 35 or higher.
I have severe damage or fractures in the spine or hip area.
I have any implants or foreign materials in the spine or hip area.
I can't stand or lie still for the imaging.
I have extra or missing lumbar vertebrae.
I am in another clinical trial that could interfere with this one.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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?
Trial Locations
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Status
Eligibility Criteria
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 …
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 are at least 20 years of age at the time of imaging acquisition
4. Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study
Exclusion Criteria:
1. Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
2. Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
3. Subjects with a BMI ≥ 35 kg/m2
4. Subjects known to have severe degenerative changes or fracture deformity in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable), as defined by the Investigator's determination of the likelihood of reasonably assessing bone mineral density of those areas
5. Subjects known to have implants, hardware, devices, or other foreign material in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable)
6. Subjects unable to attain correct position and/or remain motionless for the measurement (e.g., subjects unable to stand unassisted in the EOS unit, or to lie appropriately in the DXA scanner)
7. Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
8. Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
9. Subjects with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
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