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Value of Three-dimensional Rotational Epidurography on Percutaneous Epidural Adhesiolysis

NCT04216992 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-01-06

No results posted yet for this study

Summary

Conventional epidurography (CE) is thought to have insufficient usefulness on percutaneous epidural adhesiolysis (PEA). The investigators aimed to evaluate the association between the outcome of PEA and three dimensional-rotational epidurography (3D-RE). The investigators performed 30 PEA in 26 patients, and evaluated their post-PEA image findings. Two independent clinicians categorized and recorded the occurrence of contrast at intra-canal ventral and extra-foraminal regions on CE; and contrast at dorsal canal (DC), ventral canal (VC), dorsal foramen (DF), and ventral foramen (VF) on 3D-RE. Reproducibility was assessed using intra-class correlation coefficients (ICCs). The symptom relief after one month for the patients receiving PEA and the contrast distribution patterns of CE and 3D-RE and were determined.

Conditions

  • Failed Back Surgery Syndrome
  • Spinal Stenosis

Interventions

DEVICE

Cone beam computed tomography

The contrast agent (Omnipaque, GE Healthcare, Ireland) was instilled to confirm the epidural space. With use of a calibrated angiographic C-arm system and a postprocessing workstation, we acquired volume data sets from two dimensional digital projection images obtained to reconstruct the 3D-RE during a C-arm rotation around the patient axis.

Sponsors & Collaborators

  • Tri-Service General Hospital

    lead OTHER

Principal Investigators

  • Yi-Chih Hsu, M.D. · Department of Radiology Tri-Service General Hospital National Defense Medical Center

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2019-10-24
Completion
2019-12-06
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216992 on ClinicalTrials.gov