Clinical trial NCT06153576: The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Official title: The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Compression Fracture
Myeloma
Bone Metastases
Malignant Bone Tumour
Lymphoma
Plasmocytoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 1120
Sex: ALL
Minimum age (years): 17
Maximum age (years): 96
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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 (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.


Eligibility criteria: Inclusion Criteria:

* all patients who underwent a vertebroplasty with bone biopsy

Exclusion Criteria:

* non-vertebral bone biopsies
* not performed during vertebroplasty

Primary outcomes:
measure: Number of incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures
timeFrame: 5 years and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
References: