Monitoring of Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Procedures

NCT06174077 | Unknown

• 1 other identifier: 7993
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation. The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection

Conditions

Vertebra Compression Fracture

Keywords

Vertebra Compression Fracture; Vertebral cementoplasty; Fluoroscopy time; Fluoroscopic control; Single-level vertebral cementoplasty

Outcome Measures

Primary Outcomes (1)

• Assess the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control

  up to 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥18 years old) cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level

You may qualify if:

• Adult patient (≥18 years old)
• Man or woman
• Patient cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level between 01/06/2020 and 30/09/2020
• Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

You may not qualify if:

• Patient who expressed their opposition to the reuse of their data for research purposes
• Vertebroplasties of more than one level
• History of spinal surgery or vertebroplasty near the level concerned

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'Imagerie Interventionnelle - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Roberto Luigi CAZZATO, MD

CONTACT

33 3 69 55 16 35; robertoluigi.cazzato@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 18, 2023
• Study Start: October 6, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

FR (1)