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OpenTrials
Completed

NCT Number: 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients who underwent a vertebroplasty with bone biopsy

Exclusion criteria

  • non-vertebral bone biopsies
  • not performed during vertebroplasty

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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