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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how the human skeleton changes with age using a new low-dose x-ray system called EOS imaging. By analyzing full-body x-ray images every ten years, researchers hope to understand normal skeletal changes over time. The trial seeks participants without a history of spine surgery or serious joint issues, who have been healthy without major surgeries or conditions affecting bones or joints. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research on aging and bone health.

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 prior data suggests that the EOS imaging system is safe for skeletal structure analysis?

Research has shown that EOS imaging is a safe and well-tolerated method for capturing full-body images. Studies have found that it uses a low amount of radiation, enhancing safety. This makes it safer than traditional x-rays, particularly for full-body scans.

EOS imaging also assists in assessing leg length and planning knee and hip surgeries, demonstrating its reliability in medical settings. No major side effects have been reported in studies using this imaging system.

Overall, evidence suggests that EOS imaging is a safe choice for obtaining detailed bone images. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional X-rays or CT scans used for skeletal analysis, EOS imaging offers a full-body, low-dose radiographic option that can capture detailed 2D and 3D images. This technology allows for precise analysis of spino-pelvic parameters with significantly less radiation exposure, making it safer for repeated use, especially in younger patients. Researchers are excited about EOS imaging because it provides more comprehensive data on skeletal alignment and posture, which could lead to better diagnostic insights and treatment planning for conditions like scoliosis and other musculoskeletal disorders.

What evidence suggests that the EOS imaging system is effective for skeletal structure analysis?

Research has shown that EOS imaging, which participants in this trial will undergo, reliably examines bones. It provides clear, full-body images with significantly less radiation than regular X-rays. Studies have found that EOS can accurately measure key angles and positions of the spine and pelvis, aiding in understanding bone alignment and posture. Additionally, EOS offers image quality comparable to standard X-rays, making it a safe and effective method for studying changes in bones over time. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher Kleck, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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]

Citations

1. eos-imaging.com eos-imaging.com/us/our-expertise/imaging-solutions/eosedge

EOSedge EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566220302447

EOS® imaging: Concept and current applications in spinal ... EOS imaging is a proprietary imaging technology that was launched in 2007. Based on a gaseous particle detector with a multi-wire proportional chamber.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845382/

EOS® is reliable to evaluate spinopelvic parameters Their results further prove our point that the EOS® system is as reliable as the conventional X-ray method to evaluate spinopelvic parameters.

4. nature.com nature.com/articles/s41598-021-89958-y

Validity of the EOS-determined pelvic parameters and ... The EOS rendered accurate and reliable measurements regarding pelvic 3D position, even with positional variation, but positional variation could affect ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4763151/

EOS® biplanar X-ray imaging: concept, developments ... Image quality was found to be comparable to X-ray imaging, and the radiation dose was significantly lower (0.07 mGy for the PA spine, as compared to 0.92 mGy) [ ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01406743

Spine Reference Parameters on EOS Imaging ... So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9633236/

Sagittal Parameters of Spine and Pelvis in Young Adults ... This study was designed to analyze spinopelvic sagittal alignment measurement values obtained using the EOS imaging system in asymptomatic young adults.

8. mdpi.com mdpi.com/2813-8759/2/1/7

Clinical Application of the EOS Imaging System ... Key clinical applications of EOS imaging include lower extremity analysis, eg, leg length assessment and knee/hip arthroplasty planning, pelvic and spinal ...

9. 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 EOS ...