Percutaneous Cementoplasty With or Without Screw Fixation

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05868863
Collaborator
(none)
40
1
1
39.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: datas of medical record.

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Percutaneous Cementoplasty With or Without Screw Fixation for Bony Pelvis Lesions in Elderly Patients : Feasibility, Safety and Clinical Outcomes.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Safety of the technique by number of adverse events [Months: 3]

    collected in the medical record

  2. Number of Analgesic intake before and after the procedure [Months: 3]

    collected in the medical record

  3. Analysis Functional criteria: walking [Months: 3]

    Collect from medical record the number of patients who can walk before and after the procedure.

  4. Analysis Functional criteria: early rising [Months: 3]

    Collect from medical record the number of patients who can rise before and after the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
80 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Saint-Etienne Saint-Étienne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Sylvain GRANGE, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05868863
Other Study ID Numbers:
  • IRBN352023/CHUSTE
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Study Results

No Results Posted as of May 22, 2023