An observational study in Vertebral Compression Fracture, Myeloma and Bone Metastases, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 17 Years to 96 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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.
34 studies on the registry are indexed under Plasmacytoma; 6 are open to participants now.
Browse Plasmacytoma studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Compared within Plasmacytoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms, Plasma Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients who underwent a vertebroplasty with bone biopsy during the study period in the osteoarticular interventional radiology department of the Pasteur 2 hospital of the CHU of Nice
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures
incidental findings of neoplasia during vertebroplasty for presumed osteoporotic fractures
Time frame: 5 years and 2 months
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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