Interventional RadiologyNCT05868863
Percutaneous Cementoplasty With or Without Screw Fixation
An observational study of Interventional Radiology, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Interventional Radiology
- What is being tested?
- datas of medical record.
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Other interventional treatment at the same time and at the same location
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Sylvain GRANGE, MD
Hella TCHEIR, resident
About this study
Official title: Percutaneous Cementoplasty With or Without Screw Fixation for Bony Pelvis Lesions in Elderly Patients : Feasibility, Safety and Clinical Outcomes.
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.
Read the 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.
- Conditions
- Interventional Radiology
- Being tested
- datas of medical record.
- Keywords
- Cementoplasty, bone pelvic, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: datas of medical record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the technique
Collect from medical records the number of procedures that were completed and performed as theoretically intended.
Measured: Months: 3
Secondary outcomes (4)
Safety of the technique by number of adverse events
collected in the medical record
Measured: Months: 3
Number of Analgesic intake before and after the procedure
collected in the medical record
Measured: Months: 3
Analysis Functional criteria: walking
Collect from medical record the number of patients who can walk before and after the procedure.
Measured: Months: 3
Analysis Functional criteria: early rising
Collect from medical record the number of patients who can rise before and after the procedure.
Measured: Months: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Nov 2019
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional RadiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain GRANGE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868863
- Sponsor's protocol ID
- IRBN352023/CHUSTE
- Status last verified
- Sep 2024
- First submitted
- 18 Apr 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cementoplasty With or Without Screw Fixation for Bony Pelvis Lesions in Elderly Patients : Feasibility, Safety and Clinical Outcomes.
- ClinicalTrials.gov ID
- NCT05868863
- Acronym / sponsor ID
- IRBN352023/CHUSTE
- Conditions
- Interventional Radiology
- Keywords
- Cementoplasty, bone pelvic, elderly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporotic fractures or neoplastic lesions of the bony pelvis | – | Other: datas of medical record.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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Other interventional treatment at the same time and at the same location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | osteoporotic fractures or neoplastic lesions of the bony pelvis |
Primary outcome
Feasibility of the technique
Time frame: Months: 3
Collect from medical records the number of procedures that were completed and performed as theoretically intended.
4 secondary outcomes
Safety of the technique by number of adverse events
Time frame: Months: 3
Number of Analgesic intake before and after the procedure
Time frame: Months: 3
Analysis Functional criteria: walking
Time frame: Months: 3
Analysis Functional criteria: early rising
Time frame: Months: 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvain GRANGE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interventional Radiology, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain GRANGE, MD ((0)477127827 ext. +33, grangesylvain@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the technique (time frame: Months: 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.