Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Launched by ALPHATEC SPINE, INC. · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Bone Mineral Density Agreement Study, is comparing two types of low-dose x-ray exams—EOSedge and traditional DXA—to see how well they measure bone mineral density, which is important for understanding bone health. The main goal is to find out if the results, known as T-scores, from these two imaging methods agree with each other. This research is currently recruiting participants who are healthy and 20 years or older, and who may need imaging for spine or orthopedic evaluations as part of their regular medical care.

Participants can expect to undergo imaging either through EOSedge at a clinical site or DXA at a non-clinical site, depending on the study arm they qualify for. To join, individuals should not have any recent exposure to certain contrast agents, be free from pregnancy, and meet other specific health criteria. This study aims to help improve how we assess bone health through imaging, which could lead to better care for patients in the future.

Gender

ALL

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 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