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Not yet recruiting NCT07619404

AI Based Metal Artifact Reduction-PMAR

Observational Lmbar Spine With Screws

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lmbar Spine With Screws. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Application of AI Based Metal Artifact Reduction and Its Comparison With Orthopedic Metal Artifact Reduction (O-MAR) and Conventional Image

Overview

The study is going to enroll about 220 consecutive patients with screws in lumber spine after internal fixation surgery who underwent follow-up assessment using Incisive CT according to the department standard of care. Retrospective data sets will be reconstructed into conventional image, the O-MAR algorithm, and Precise-MAR. Three blinded, independent radiologists evaluate both qualitative and quantitative analysis of image quality of surrounding tissue and artifact. Statistical analysis included the Friedman test, Wilcoxon signed-rank test, and Levene test.

Primary outcome measures

  • Image Quality-4 Likert Scale [Time frame: From the date of image reconstruction completion until the date of image read completion. Anticipate 2Months.]

Eligibility criteria

Inclusion criteria

  • Images come from patients aged ≥ 18 years,
  • Images come from patients with screws in lumber spine after internal fixation surgery underwent follow up Incisive CT scan;
  • Images come from patients who comply with the requirements of informed consent at the study site.

Exclusion criteria

  • Patients with other metal objects inside or outside the body
  • There is movement during the CT scan, causing by breathing etc. artifact affecting image quality
  • Data is considered unsuitable for enrollment based on the investigator's evaluation due to incomplete clinical data or radiological information etc.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07619404 · SEF-2025-301454

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗