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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Completed
CT.gov ID
NCT06153576
Collaborator
(none)
1,120
1
74
15.1

Study Details

Study Description

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: We 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.

We therefore recommend that biopsies be taken systematically when performing vertebroplasty.

Study Design

Study Type:
Observational
Actual Enrollment :
1120 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures [5 years and 2 months]

    incidental findings of neoplasia during vertebroplasty for presumed osteoporotic fractures

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 96 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • all patients who underwent a vertebroplasty with bone biopsy
Exclusion Criteria:
  • non-vertebral bone biopsies

  • not performed during vertebroplasty

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU NICE Nice Alpes Maritimes France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT06153576
Other Study ID Numbers:
  • 23Imagerie03
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2023