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NCT Number: NCT05868863

Percutaneous Cementoplasty With or Without Screw Fixation

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.

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Key information

Conditions

Interventional Radiology

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

Location contact

Hella TCHEIR, resident

SUB_INVESTIGATOR

Sylvain GRANGE, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Feasibility of the technique

    Time frame: Months: 3

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

Secondary outcomes

  1. Safety of the technique by number of adverse events

    Time frame: Months: 3

    collected in the medical record

  2. Number of Analgesic intake before and after the procedure

    Time frame: Months: 3

    collected in the medical record

  3. Analysis Functional criteria: walking

    Time frame: Months: 3

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

  4. Analysis Functional criteria: early rising

    Time frame: Months: 3

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hella TCHEIR, resident

CONTACT

[email protected]

(0)477127827 ext. +33

Sylvain GRANGE, MD

CONTACT

[email protected]

(0)477127827 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 22, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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