Bone Mineral Density Precision Study
ConditionIndicated for EOSedge Imaging
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 low-dose x-ray exams. The main question it aims to answer is:
What is the precision measurement between the BMD assessments from 2 x-ray exams?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects 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)
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 or the subject's legal representative 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
Single group
Treatments tested in this trial
EOSedge imaging
RadiationFull body or full spine image
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Subjects indicated for EOSedge imagingOther 1 intervention
Trial outcomes
Primary outcomes
1
AP Spine BMD Precision
Calculation of EOSedge BMD from the 2 exams 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. Precision error will be calculated from the 2 exams.
Time frame
1 daySecondary outcomes
1
Hip BMD Precision
Calculation of EOSedge BMD from the 2 exams will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the hip (femoral necks). Precision error will be calculated from the 2 exams.
Time frame
1 day2
Lateral L2-L3 Precision
Calculation of EOSedge BMD from the 2 exams will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the spine (lateral L2-L3). Precision error will be calculated from the 2 exams.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov