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

NCT06153576 | Completed

• 1 other identifier: 23Imagerie03
• Study Type: observational
• Target: 1,120
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Compression Fracture; Myeloma; Bone Metastases; Malignant Bone Tumour; Lymphoma; Plasmocytoma

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 17 Years - 96 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• all patients who underwent a vertebroplasty with bone biopsy

You may not qualify if:

• non-vertebral bone biopsies
• not performed during vertebroplasty

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Lymphoma; Plasmacytoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: January 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

FR (1)