ATEC IOA Imaging for Scoliosis

TP
KP
Overseen ByKorine Pagulayan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging tool called the ATEC IntraOperative Alignment (IOA) Imaging Platform for individuals undergoing surgery to correct adult spinal deformities. The researchers aim to determine if this tool provides better spine alignment visualization during surgery compared to standard x-rays. The trial seeks participants who require spinal fusion surgery on their lower spine or have specific spine issues, such as scoliosis or other spinal deformities. As an unphased trial, it offers patients the chance to contribute to advancements in surgical imaging technology.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ATEC IOA Imaging Platform is safe for intraoperative imaging?

Research on the ATEC IntraOperative Alignment (IOA) Imaging Platform shows it could be a helpful tool for spine surgery. This technology uses advanced imaging to help surgeons see and align the spine better during operations. The information provided does not report any specific safety issues or negative effects directly linked to this imaging platform.

This trial does not test a new drug or invasive treatment; it focuses on an imaging tool used during surgery. Generally, this type of technology poses a lower risk of harm compared to medications or surgical procedures. The trial is labeled as "Not Applicable" for phase, indicating it tests the tool's effectiveness rather than its safety, often suggesting the tool is considered low-risk.

For those considering joining a trial using this platform, it may be reassuring to know that imaging tools like these aim to improve surgical results with minimal direct impact on patients. Always discuss any concerns with the trial team or your healthcare provider.12345

Why are researchers excited about this trial?

Researchers are excited about the ATEC IntraOperative Alignment (IOA) Imaging Platform because it offers a new way to enhance surgical precision for scoliosis. Unlike traditional imaging methods, which rely heavily on standard 36" cassette imaging, the ATEC IOA platform integrates advanced imaging techniques that provide real-time alignment feedback during surgery. This innovative approach could improve surgical outcomes by ensuring that spinal corrections are more accurate and tailored to each patient's unique anatomy. By potentially reducing the need for follow-up surgeries and improving recovery times, this technology represents a promising advancement in scoliosis treatment.

What evidence suggests that the ATEC IOA Imaging Platform is effective for scoliosis?

Research has shown that the ATEC IntraOperative Alignment (IOA) Imaging Platform can enhance the precision of spine surgeries. This technology employs artificial intelligence (AI) to accurately measure alignment, potentially improving outcomes for patients with spinal issues like scoliosis. During this trial, participants will undergo imaging with the ATEC IOA Imaging Platform during surgery. One study found that this technology's alignment assessments matched traditional methods closely, achieving an accuracy of up to 91.2%. The AI system aids in planning and making real-time adjustments during surgery, which may reduce complications and speed up recovery. Overall, this technology holds promise for improving surgery outcomes in scoliosis treatment.26789

Who Is on the Research Team?

TP

Themistocles Protopsaltis, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with scoliosis or spinal deformity who need surgery to fuse two or more levels of their spine. Participants must be fully grown, able to give consent, and have certain measurements showing significant spinal curvature.

Inclusion Criteria

I am able to understand and agree to participate in the study.
* Coronal cobb angle \>20 degrees
* Pelvic Tilt \>25degrees
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants undergo preoperative standing electronic optical scan (EOS) radiographs

1 day
1 visit (in-person)

Intra-operative

Participants receive standard 36" cassette imaging and imaging with the ATEC IOA Imaging Platform during surgery

Up to 1 hour

Post-operative

Participants receive first-erect postoperative standing EOS radiographs

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in pelvic incidence and other parameters up to 6 months post-operative

6 months

End of study

Final assessments including intraclass correlation coefficient (ICC) for radiographic measurements

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • ATEC IntraOperative Alignment (IOA) Imaging Platform

Trial Overview

The study compares a new imaging tool called the ATEC IOA Imaging Platform with standard long x-rays during spine surgery, aiming to see which method gives more precise alignment results.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Spinal DeformityExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

ATEC Launches EOS Insight, an End-To- ...

EOS Insight provides access to integrated, efficient point-of-care applications including AI-driven alignment calculation, informed 3D-surgical ...

Artificial intelligence in early onset scoliosis: a scoping review

Predictive models (27.3%) estimated prolonged hospital stay, unplanned reoperation, or postoperative complications. Mean accuracy was 91.2% ( ...

ATEC Project Echo 2 Deck VF webcast

Correlation of. Functional Outcomes and Sagittal Alignment After Long Instrumented Fusion for Degenerative Thoracolumbar Spinal Disease. Spine: Volume 43, Issue ...

4.

atecspine.com

atecspine.com/eos/

EOS Imaging

A data-informed, peri-operative platform that enables spino-pelvic alignment assessments, patient-specific surgical planning, patient trends, and surgeon ...

EOS Insight: Revolutionizing Spine Surgery with AI

Takeaki Ishizawa highlight how AI integrates preoperative and intraoperative imaging to improve surgical precision. By analyzing both types of ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34479187/

Impact of an intraoperative coronal spinal alignment ...

The purpose of this study was to test the feasibility of using the CAMNBS for coronal spinal alignment and to evaluate its usefulness in ...

Outcomes of Vertebral Body Tethering in Adolescent ...

Patients who had mean FE curve magnitude of ≤35° were 88% successful compared with only 60% in those with >35° on FE (p = 0.0021). Patients ...

Fukuoka Final Program

safe and effective surgical intervention in this population. 291. Surgical Safety and Outcomes of Adult Spinal Deformity in. Patients Aged 80 ...

Advancing computer vision in spine surgery

Their classifier achieved accuracy rates of 93.15% on lateral views, 88.98% on anteroposterior views, and 91.08% on fused images, notably including cases with ...