X-ray for Bone Density
SM
Overseen BySr. Manager, Clinical Studies
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Alphatec Spine, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of 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 is for adults at least 20 years old needing full-spine or whole-body x-ray exams with EOSedge imaging. Participants must be able to stand still for the exam and not be pregnant, have implants in the measurement area, severe spine deformities, a BMI over 35, recent contrast agents use, or an abnormal number of lumbar vertebrae.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)
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
I am 20 years old or older.
Exclusion Criteria
Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
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)
I can stand or lie still for scans without help.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Imaging
Participants undergo two EOSedge imaging exams to assess bone mineral density
1 day
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging
1-2 weeks
Treatment Details
Interventions
- EOSedge imaging
Trial Overview The study tests the precision of bone mineral density measurements between two low-dose x-ray exams using EOSedge imaging technology. It aims to determine how consistent BMD assessments are when taken from different x-rays.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Subjects indicated for EOSedge imagingExperimental Treatment1 Intervention
Subject receiving EOSedge imaging as SOC will also receive an additional EOSedge scan.
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Who Is Running the Clinical Trial?
Alphatec Spine, Inc.
Lead Sponsor
Trials
9
Recruited
890+
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