Vertebral FractureNCT05071625
CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation
An observational study of Vertebral Fracture and Vertebral Trauma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fracture, Vertebral Trauma
- What is being tested?
- percutaneous vertebroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2019to 15 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with a percutaneous vertebroplasty in our centre between 01/07/2015 and 01/07/2020 under combined CT/fluoroscopy guidance
Who may be able to join
- PVP performed between July 2015-July 2020 under combined CT and fluoroscopy guidance;
- Previous PF for traumatic non-neurological thoracolumbar vertebral fracture;
- Imaging evidence of vertebral non-union;
- Pain and functional impairment persisting for more at least one month after PF;
- Informed patient consent for PVP procedure under CT and fluoroscopy guidance;
- Previous multidisciplinary case discussion between spine surgeons and interventional radiologists.
Who cannot join
- Age inferior to 18 years old
- Absence of complications due to orthopaedic hardware;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospectice Evaluation of the Feasibility and Usefulness of a Percutaneous Vertebroplasty Performed on Patients Treated With Posterior Fixation Suffering Non-union After a Traumatic Non-neurologic Vertebral Fracture
Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option.
The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation.
All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.
- Conditions
- Vertebral Fracture, Vertebral Trauma
- Being tested
- percutaneous vertebroplasty
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous vertebroplastyProcedure or surgery
percutaneous vertebroplasty under combined CT/fluoroscopy guidance for non-union after posterior fixation performed for a traumatic non-neurologic thoraco-lumbar vertebral fracture.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty
Numeric Pain Rate Scale (from 0 to 10 points, where 0 no pain, 10 maximum pain)
Measured: 18 months
Secondary outcomes (2)
Technical success of the percutaneous vertebroplasty
criteria of cement filling rate of vertebral body established by the authors
Measured: 18 months
Safety of the procedure
Complication rate during and after the procedure using CIRSE adverse event reports
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start31 Mar 2019
- Primary completion1 Jul 2020
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071625
- Sponsor's protocol ID
- 21Imagerie02
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan has been established
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospectice Evaluation of the Feasibility and Usefulness of a Percutaneous Vertebroplasty Performed on Patients Treated With Posterior Fixation Suffering Non-union After a Traumatic Non-neurologic Vertebral Fracture
- ClinicalTrials.gov ID
- NCT05071625
- Acronym / sponsor ID
- 21Imagerie02
- Conditions
- Vertebral Fracture, Vertebral Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 8 Oct 2021 (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.
Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option.
The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation.
All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with a percutaneous vertebroplasty in our centre between 01/07/2015 and 01/07/2020 under combined CT/fluoroscopy guidance
Key inclusion criteria (6 listed)
- PVP performed between July 2015-July 2020 under combined CT and fluoroscopy guidance;
- Previous PF for traumatic non-neurological thoracolumbar vertebral fracture;
- Imaging evidence of vertebral non-union;
- Pain and functional impairment persisting for more at least one month after PF;
- Informed patient consent for PVP procedure under CT and fluoroscopy guidance;
Key exclusion criteria (2 listed)
- Age inferior to 18 years old
- Absence of complications due to orthopaedic hardware;
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 |
|---|---|---|
| percutaneous vertebroplastypercutaneous vertebroplasty under combined CT/fluoroscopy guidance for non-union after posterior fixation performed for a traumatic non-neurologic thoraco-lumbar vertebral fracture. | Procedure or surgery | – |
Primary outcome
Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty
Time frame: 18 months
Numeric Pain Rate Scale (from 0 to 10 points, where 0 no pain, 10 maximum pain)
2 secondary outcomes
Technical success of the percutaneous vertebroplasty
Time frame: 18 months
Safety of the procedure
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No. no data sharing plan has been established
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Vertebral Fracture and Vertebral Trauma, run by Centre Hospitalier Universitaire de Nice 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty (time frame: 18 months). 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 8 Oct 2021.