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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05868863
Other study ID # IRBN352023/CHUSTE
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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