Comparing bone mineral density measurements using EOSedge imaging
Precision Assessment of Bone Mineral Density (BMD) Measurement With EOSedge™ - BMD Precision Study
This study is testing a new type of low-dose x-ray to see how well it measures bone density in people who need full-spine or whole-body scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Alphatec Spine, Inc. Industry-sponsored |
| Locations | 1 site (Fishers, Indiana) |
| Trial ID | NCT06830811 on ClinicalTrials.gov |
What this trial studies
This research aims to collect medical imaging data to compare bone mineral density (BMD) measurements from two low-dose x-ray exams using EOSedge technology. The study will enroll 30 subjects who are indicated for full-spine or whole-body radiography. Participants will undergo two EOSedge exams, with repositioning between the scans to ensure accurate measurement. Demographic and diagnostic information will also be collected to support the analysis of BMD precision.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 and older who require full-spine or whole-body radiography for orthopedic evaluations.
Not a fit: Patients who are pregnant, have a high BMI, or have severe degenerative changes in the measurement area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of bone mineral density assessments, leading to better diagnosis and treatment planning for patients with orthopedic conditions.
How similar studies have performed: While this approach is focused on precision measurement, similar imaging techniques have shown promise in improving diagnostic accuracy in orthopedic assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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) 2. Male or female subjects who are at least 20 years of age at the time of imaging acquisition 3. 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 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
Where this trial is running
Fishers, Indiana
- OrthoIndy — Fishers, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Sr. Manager, Clinical Studies
- Email: vshainsky@atecspine.com
- Phone: 858-603-3139
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.