Full Body Radiographs for Skeletal Structure Analysis

Overseen By David Calabrese

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Spine surgery, Cancer, Rheumatologic disorders, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment EOS imaging system?

The EOS imaging system is effective for evaluating and monitoring conditions like scoliosis and osteoarthritis, offering accurate images with low radiation exposure. It provides detailed 3D images of the skeleton, which helps in assessing spinal and limb balance and skeletal maturity. ^{1 2 3 4 5}

Is the EOS imaging system safe for humans?

The EOS imaging system is generally considered safe for humans as it delivers a very low radiation dose compared to conventional X-ray systems, which reduces the risk of radiation-induced cancer, especially in adolescents undergoing repetitive imaging. ^{1 2 5 6 7}

How does the EOS imaging system treatment differ from other treatments for skeletal structure analysis?

The EOS imaging system is unique because it provides full-body 2D and 3D images with a very low radiation dose, capturing both front and side views simultaneously, which is not possible with conventional X-rays. This allows for a comprehensive analysis of the skeletal structure, particularly useful for conditions like scoliosis and osteoarthritis, while minimizing radiation exposure. ^{1 2 3 4 5}

What is the purpose of this trial?

A study of the skeletal structure and how the structure changes over time. The aim of the study is to evaluate the skeleton in 10 year increments to determine an understanding of the normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS) can be used to evaluate the whole body to see changes in the bone structure over time. Subjects will be asked to undertake one x-ray analysis of their whole body skeletal structure. There will be 25 male and 25 female subjects per decade. The averaging of the measured skeletal parameters will provide information on changes over time generating a standardized expectation of general changes in skeletal structure as participants age.

Research Team

Christopher Kleck, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for men and women aged 21-85 with no history of spine surgery. It's not suitable for those who've had knee replacements, severe joint arthritis, spinal trauma or surgery, certain disability scores, inflammatory disorders, significant past fractures or surgeries on the pelvis or lower limbs, are pregnant, have a history of cancer or a BMI over 37.

Inclusion Criteria

I am between 21 and 85 years old and have never had spine surgery.

Exclusion Criteria

I have had surgery on my spine or brain.

I have been diagnosed with spondylitis.

I have had a spinal fracture or injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo a single EOS biplanar x-ray imaging session to analyze whole body skeletal structure

1 day

1 visit (in-person)

Follow-up

Participants' radiographic data is analyzed for age-related changes in skeletal structure

10 years

Treatment Details

Interventions

• EOS imaging

Trial Overview The study uses EOS imaging—a low dose full-body x-ray system—to observe changes in skeletal structure every decade to understand normal aging patterns. With an equal number of male and female volunteers per age group (25 each), it aims to create a standard expectation of skeletal changes as people get older.

Participant Groups

Group I: asymptomatic EOS Imaging Experimental Treatment 1 Intervention

patients that qualify for study and EOS imaging to analyze spino-pelvic parameters

EOS imaging is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as EOS Imaging System for:

• Orthopedic assessments
• Scoliosis monitoring
• Musculoskeletal disorders

Approved in United States as EOS Imaging System for:

• Orthopedic assessments
• Scoliosis monitoring
• Musculoskeletal disorders
• Hip and knee replacement surgeries

Approved in Canada as EOS Imaging System for:

• Orthopedic assessments
• Scoliosis monitoring
• Musculoskeletal disorders

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

The EOS imaging system provides accurate grading of osteoarthritis (OA) in the knee, comparable to conventional radiographs, based on a study of 142 patients using the Kellgren and Lawrence score and OARSI system.

EOS images demonstrate excellent reliability for measuring joint space and grading OA, but may not always clearly show subchondral sclerosis, suggesting that conventional radiographs should still be used alongside EOS for comprehensive assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the EOS imaging system as accurate as conventional radiography in grading osteoarthritis of the knee? Koliogiannis, VKA., Brandlhuber, M., Messerschmidt, V., et al.[2021]

The EOS(®) 2D/3D X-ray imaging system shows comparable or better spinal image quality than traditional X-ray methods, while significantly reducing radiation exposure—over five times lower for certain spine views.

However, the current evidence is limited, with no reported patient health outcomes, indicating a need for further clinical studies to assess how EOS(®) impacts patient management and outcomes in orthopaedic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical effectiveness of EOS 2D/3D X-ray imaging system. Wade, R., Yang, H., McKenna, C., et al.[2021]

The innovative EOS® low-dose X-ray biplanar imager provides highly reproducible 3D measurements of spinal deformities, with an intraclass correlation coefficient (ICC) greater than 0.9, indicating excellent reliability.

Intra- and inter-observer reproducibility for 3D measures was significantly better than for 2D measures, with mean absolute differences of less than 2° or 2 mm, making 3D assessments more accurate for evaluating sagittal balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sagittal balance measures are more reproducible when measured in 3D vs in 2D using full-body EOS® images. Okamoto, M., Jabour, F., Sakai, K., et al.[2020]

The EOS-imaging system provides high-quality biplanar imaging for assessing skeletal maturity in adolescents with idiopathic scoliosis, demonstrating excellent reliability with an interobserver agreement of ICC = 0.997.

The new EOS workflow allows for efficient skeletal maturity assessment and consistent bracing recommendations, making it suitable for busy clinical settings, with a significant reduction in time costs for radiology departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential spine-hand radiography for assessing skeletal maturity with low radiation EOS imaging system for bracing treatment recommendation in adolescent idiopathic scoliosis: a feasibility and validity study. Lau, LCM., Hung, ALH., Chau, WW., et al.[2022]

The EOS 2D/3D radio-imaging device provides high-quality digital radiographic images of the entire skeleton while using a very low dose of radiation, making it safer for patients compared to traditional imaging methods.

This technology allows for simultaneous capture of both front and side X-ray images, enabling detailed 3D reconstructions that are particularly useful for assessing balance disorders in the spine and lower limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal imaging in progress: the EOS imaging system. Wybier, M., Bossard, P.[2022]

The EOS imaging system delivers a significantly lower effective radiation dose (between 86 and 140 μSv) for full spine imaging in scoliotic adolescents compared to conventional X-ray systems, which helps reduce the associated cancer risk.

The lifetime attributable risk (LAR) of developing cancer from this exposure ranges from 0.81×10^-6 to 6.00×10^-6, with female patients facing a statistically higher risk than male patients, highlighting the importance of monitoring radiation exposure in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of cumulative effective dose and cancer risk from repetitive full spine imaging using EOS system: Impact to adolescent patients of different populations. Law, M., Ma, WK., Chan, E., et al.[2018]

The EOS imaging system delivers an estimated effective dose of 290 μSv for adults and 200 μSv for children during full spine examinations, which is comparable to conventional radiological systems, indicating its safety for patient exposure.

Image quality from the EOS system is maintained at a high standard, with a maximum detective quantum efficiency (DQE) of 13%, suggesting that it effectively balances image quality with radiation dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational and patient exposure as well as image quality for full spine examinations with the EOS imaging system. Damet, J., Fournier, P., Monnin, P., et al.[2017]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Is the EOS imaging system as accurate as conventional radiography in grading osteoarthritis of the knee? [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical effectiveness of EOS 2D/3D X-ray imaging system. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Sagittal balance measures are more reproducible when measured in 3D vs in 2D using full-body EOS® images. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Sequential spine-hand radiography for assessing skeletal maturity with low radiation EOS imaging system for bracing treatment recommendation in adolescent idiopathic scoliosis: a feasibility and validity study. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Musculoskeletal imaging in progress: the EOS imaging system. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of cumulative effective dose and cancer risk from repetitive full spine imaging using EOS system: Impact to adolescent patients of different populations. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Occupational and patient exposure as well as image quality for full spine examinations with the EOS imaging system. [2017]