X-ray for Bone Density

Overseen By Sr. Manager, Clinical Studies

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alphatec Spine, Inc.

Must not be taking: Contrast agents, Radionuclides

Disqualifiers: Pregnancy, BMI ≥ 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the accuracy of bone density scans using two low-dose x-ray exams. Researchers aim to determine the precision of bone mineral density (BMD) measurements with the EOSedge imaging system, a type of x-ray imaging technology. The trial seeks participants who require full-spine or whole-body x-rays, such as those preparing for spine surgery. Participants should not have recent exposure to certain contrast agents or severe bone issues that could affect the scan. The study aims to improve the accuracy and reliability of bone scans, aiding in better diagnosis and management of bone health. As an unphased study, it offers participants the chance to contribute to advancements in imaging technology that could enhance bone health diagnostics.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have used contrast agents or radionuclides within 7 days before the imaging.

What prior data suggests that EOSedge imaging is safe for bone density assessment?

Research has shown that EOSedge imaging is safe and easy to use for checking bone density. Studies have found that the cancer risk from these low-dose x-ray exams is extremely low, affecting only 0.02 to 0.25 out of a million people. This indicates that radiation exposure is minimal. EOSedge uses less radiation compared to some other imaging methods, benefiting both adults and children. The device is as safe and effective as earlier versions approved by the FDA. Overall, evidence suggests that EOSedge imaging is a safe choice for bone density tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EOSedge imaging technique for assessing bone density because it offers a new approach that could enhance diagnostic precision. Unlike traditional X-ray methods, EOSedge provides 3D imaging with lower radiation exposure, which is safer for patients requiring frequent scans. This advanced imaging can capture detailed bone structures and alignment, potentially leading to more accurate assessments and better-informed treatment plans for bone-related conditions.

What evidence suggests that EOSedge imaging is effective for measuring bone mineral density?

Studies have shown that EOSedge imaging, which participants in this trial will receive, significantly reduces radiation exposure compared to standard X-rays, making it safer for both adults and children. This technology captures detailed images quickly, aiding in accurate assessments of bone strength. Although specific data on EOSedge's ability to predict fracture risk is lacking, it generally assists doctors in making treatment decisions. Overall, the EOSedge system offers the advantages of lower radiation and fast imaging, which are beneficial for regular bone strength checks. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Subjects indicated for EOSedge imaging Experimental Treatment 1 Intervention

Subject receiving EOSedge imaging as SOC will also receive an additional EOSedge scan.

Who Is Running the Clinical Trial?

Alphatec Spine, Inc.

Lead Sponsor

Trials

9

Recruited

890+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06659055

Bone Mineral Density Agreement Study Between EOSedge ... The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11252187/

Health technology assessment in musculoskeletal radiology Data showed that EOSedge provides significant dose reduction factors for full spine imaging in both adults and children as compared to the ...

3. withpower.com withpower.com/trial/phase-indicated-for-eosedge-imaging-8-2024-0ef6f

EOSedge vs DXA Imaging for Bone Density Measurement It is effective in predicting fracture risk and guiding treatment decisions. However, there is no specific data provided about EOSedge Imaging in the context ...

4. canberraimaging.com.au canberraimaging.com.au/wp-content/uploads/2024/11/J241441-CIG-EOSedge-Value-Summary-A4-FA.pdf

EOSedgeTM: Value Summary EOSedge is capable of fast image capture for high patient throughput and ability to maximise number of daily exams. • EOSedge images and data ...

5. researchgate.net researchgate.net/publication/235894312_The_EOS_2D3D_X-ray_imaging_system_A_cost-effectiveness_analysis_quantifying_the_health_benefits_from_reduced_radiation_exposure

The EOS 2D/3D X-ray imaging system: A cost-effectiveness ... Results: Standard X-ray is associated with a maximum health loss of 0.001 QALYs, approximately 0.4 of a day in full health, while the loss with ...

6. med.uth.edu med.uth.edu/ortho/ut-ortho-now-has-eosedge/

UT Ortho – EOSedge | McGovern Medical School It can take about 1 to 3 days for the 3D data to be generated. Safe imaging is our top priority. We take every precaution to reduce radiation exposure across ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K202394.pdf

EOS imaging September 16, 2020 Mr. Bernard Ismael Quality ... Performance data further demonstrates that modified EOSedge is as safe and effective as the cleared EOSedge System. (K192079). Thus, modified ...