Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153576
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-11-23
Brief Title:
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 5 044 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
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 5 044 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None