- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06153576
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. The question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? Methods: The investigators carried out a single-centre retrospective study at Nice University Hospital.
From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients.
The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a coagulation test.
The imaging work-up systematically included MRI, unless contraindicated, in which case CT alone was performed.
Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic guidance. The systematic biopsy sample was then sent to the anatomopathology department for analysis.
Findings :
The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion.
All the incidental findings were haemopathies, including 4 myelomas and one lymphoma.
Conclusion :
These results highlight the good performance of MRI in distinguishing osteoporotic vertebral fractures from solid tumour metastases.
However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion.
The investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alpes Maritimes
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Nice, Alpes Maritimes, France, 06000
- CHU Nice
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- all patients who underwent a vertebroplasty with bone biopsy
Exclusion Criteria:
- non-vertebral bone biopsies
- not performed during vertebroplasty
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures
Time Frame: 5 years and 2 months
|
incidental findings of neoplasia during vertebroplasty for presumed osteoporotic fractures
|
5 years and 2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms by Site
- Wounds and Injuries
- Musculoskeletal Diseases
- Bone Diseases
- Neoplasms, Plasma Cell
- Spinal Injuries
- Back Injuries
- Bone Neoplasms
- Fractures, Bone
- Plasmacytoma
- Spinal Fractures
- Fractures, Compression
Other Study ID Numbers
- 23Imagerie03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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