Status:
RECRUITING
Bone Mineral Density Precision Study
Lead Sponsor:
Alphatec Spine, Inc.
Conditions:
Indicated for EOSedge Imaging
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
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: ...
Detailed Description
This is a single-center, prospective, precision study of 30 subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging. From the potential pool of EOSedge examinees, sc...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
November 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06830811
Start Date
November 13 2024
End Date
March 1 2025
Last Update
February 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OrthoIndy
Fishers, Indiana, United States, 46038