Verticalization Criteria for Pelvic Ring Tumor Lesions Treated by Percutaneous Screw Fixation and Cementoplasty

Verticalization Criteria for Pelvic Ring Tumor Lesions Treated by Percutaneous Screw Fixation and Cementoplasty: A Retrospective Multicentric Study

Evaluate early functional outcomes following percutaneous screw fixation or cementoplasty for pelvic ring tumor lesions.

Study Overview

• Status: Completed
• Conditions: Pelvic Ring Tumor Lesions

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• France
  • Nice, France
    • CHU Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.

Description

Inclusion :

- Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.

Exclusion criteria :

• minors
• incompetent adults
• refused to participate in the study
• pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verticalization	Time (day) required following the procedure to obtain verticalization	During hospitalization, mainly less than 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	adverse event during procedure or hospitalization	During hospitalization, and follow-up
Duration of hospitalization	The duration of hospitalization will be measured between the day and time of arrival at the hospital and the day and time of discharge from the hospital	Mainly less than 3 days
Long-term effectiveness in preventing pathological fractures of the pelvic ring	Absence of pelvic ring fracture during follow-up	3 months after the procedure, and during follow-up, up to 5 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Estimated): December 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 23Imagerie02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No