Percutaneous Cementoplasty With or Without Screw Fixation

Recruiting

• Conditions: Interventional Radiology
• Interventions: Other: datas of medical record.

• Registration Number: NCT05868863
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Bone pathologies such as fragility fractures and neoplastic bone lesions are frequently encountered in rheumatology. When these lesions affect the pelvis, they are responsible both for pain that is sometimes very disabling, but also for significant functional disorders due to their location.

Different methods may be used to treat these lesions. The current challenge is to use less and less invasive techniques such as radio-guided cementoplasty to be able to treat all types of people, especially the most fragile. Among the elderly, the prevalence of these bone pathologies continues to increase due to the aging of the population and the improvement of diagnostic means.

Detailed Description

The aim of this study is to retrospectively evaluate the outcome of cementoplasty of the pelvis in people aged 80 and over suffering from osteoporotic fractures or neoplastic lesions of the bony pelvis AND to assess the feasibility, safety and efficiency of this treatment.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2023-04-18
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with lesion of the bony pelvis treated by percutaneous cementoplasty with or without screw fixation at university hospital center of Saint-Etienne between January 1st 2012 and February 28th 2023

Exclusion Criteria

• Other interventional treatment at the same time and at the same location

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
osteoporotic fractures or neoplastic lesions of the bony pelvis	datas of medical record.	Patient aged 80 and over suffering from osteoporotic fractures or neoplastic lesions of the bony pelvis treated by percutaneous cementoplasty with or without screw fixation at university hospital center of Saint-Etienne between January 1st 2012 and February 28th 2023 will be included. Analysis datas of medical record.

Primary Outcome Measures

Name	Time	Method
Feasibility of the technique	Months: 3	Collect from medical records the number of procedures that were completed and performed as theoretically intended.

Secondary Outcome Measures

Name	Time	Method
Safety of the technique by number of adverse events	Months: 3	collected in the medical record
Number of Analgesic intake before and after the procedure	Months: 3	collected in the medical record
Analysis Functional criteria: walking	Months: 3	Collect from medical record the number of patients who can walk before and after the procedure.
Analysis Functional criteria: early rising	Months: 3	Collect from medical record the number of patients who can rise before and after the procedure.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France