The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Vertebral Compression Fracture Myeloma Bone Metastases Malignant Bone Tumour Lymphoma Plasmocytoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* all patients who underwent a vertebroplasty with bone biopsy

Exclusion Criteria

* non-vertebral bone biopsies
* not performed during vertebroplasty

Minimum Eligible Age

17 Years

Maximum Eligible Age

96 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU NICE

Nice, Alpes Maritimes, France

Site Status

Countries

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France

Other Identifiers

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23Imagerie03

Identifier Type: -

Identifier Source: org_study_id