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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06153576
• Other study ID #: 23Imagerie03
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1120
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 96 Years

Eligibility

Inclusion Criteria:

• all patients who underwent a vertebroplasty with bone biopsy

Exclusion Criteria:

• non-vertebral bone biopsies

• not performed during vertebroplasty

Related Conditions & MeSH terms

• Bone Metastases
• Bone Neoplasms
• Fractures, Bone
• Fractures, Compression
• Lymphoma
• Myeloma
• Plasmacytoma
• Plasmocytoma
• Spinal Fractures
• Vertebral Compression Fracture

Locations

Country	Name	City	State
France	CHU NICE	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years and 2 months