Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorAlphatec Spine, Inc.
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
DXA Imaging
RadiationDXA imaging: lumbar spine, bi-lateral femoral necks
EOSedge imaging
RadiationFull body or full spine image
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: Healthy VolunteersOther 2 interventions
Group B: Subjects indicated for EOSedge imagingOther 1 intervention
Trial outcomes
Primary outcomes
1
AP Spine T-score Agreement
Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass on four lumbar vertebrae (L1-L4) in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the spine (AP L1-L4) exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems.
Time frame
between 0-60 daysSecondary outcomes
1
Hip T-score Agreement
Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the femoral neck in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the hip exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems.
Time frame
between 0-60 daysSponsors and contacts
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Source ClinicalTrials.gov