Percutaneous Cementoplasty With or Without Screw Fixation

Interventional Radiology Clinical Trial

Official title:

Percutaneous Cementoplasty With or Without Screw Fixation for Bony Pelvis Lesions in Elderly Patients : Feasibility, Safety and Clinical Outcomes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868863
• Other study ID #: IRBN352023/CHUSTE
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: June 2027

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Sylvain GRANGE, MD
• Phone: (0)477127827
• Email: grangesylvain[@]hotmail.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interventional Radiology

Intervention

Other:
• datas of medical record.
Analysis datas of medical record: Feasibility of the technique Safety of the technique with evaluation by Cardiovascular and Interventional Radiological Society of Europe (CIRSE) scale Analgesic intake before and after the procedure Functional criteria: early rising, walking

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the technique	Collect from medical records the number of procedures that were completed and performed as theoretically intended.	Months: 3
Secondary	Safety of the technique by number of adverse events	collected in the medical record	Months: 3
Secondary	Number of Analgesic intake before and after the procedure	collected in the medical record	Months: 3
Secondary	Analysis Functional criteria: walking	Collect from medical record the number of patients who can walk before and after the procedure.	Months: 3
Secondary	Analysis Functional criteria: early rising	Collect from medical record the number of patients who can rise before and after the procedure.	Months: 3