Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
Recruiting now · Not applicable
Conditions studied: Healthy, Indicated for EOSedge Imaging
In brief
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?
Key facts
- Study ID
- NCT06659055
- Run by
- Alphatec Spine, Inc.
- People needed
- 214
- Starts
- 2024-09-11
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2025-02-14
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
- Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
- Subjects with a BMI ≥ 35 kg/m2
- 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
- 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)
- 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)
- Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
- Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
- 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
Where it is running
- Honor Health — Phoenix, Arizona, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- ATEC Carlsbad — Carlsbad, California, United States
- ATEC Mephis — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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