Percutaneous Cementoplasty With or Without Screw Fixation

NCT05868863 | Recruiting

• 1 other identifier: IRBN352023/CHUSTE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Interventional Radiology

Keywords

Cementoplasty; bone pelvic; elderly

Outcome Measures

Primary Outcomes (1)

• Feasibility of the technique

  Collect from medical records the number of procedures that were completed and performed as theoretically intended.

  Months: 3

Secondary Outcomes (4)

• Safety of the technique by number of adverse events

  Months: 3

• Number of Analgesic intake before and after the procedure

  Months: 3

• Analysis Functional criteria: walking

  Months: 3

• Analysis Functional criteria: early rising

  Months: 3

Study Arms (1)

osteoporotic fractures or neoplastic lesions of the bony pelvis

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.

Other: datas of medical record.

Interventions

datas of medical record. OTHER

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

osteoporotic fractures or neoplastic lesions of the bony pelvis

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 will be included.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

Study Officials

• Sylvain GRANGE, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain GRANGE, MD

CONTACT

(0)477127827; grangesylvain@hotmail.fr

Hella TCHEIR, resident

CONTACT

(0)477127827; hellatcheir@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 22, 2023
• Study Start: November 1, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)