NCT04533217 Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
| NCT ID | NCT04533217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spine Centre of Southern Denmark |
| Condition | Vertebral Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-03-29 |
| Primary Completion | 2025-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).
Eligibility Criteria
Inclusion Criteria: * known multiple myeloma * verified lesion(s) between Th6-L5 * 4 or less fractures * relevant pain in 3 months or less * vertebroplasty can be performed in one procedure * VAS 5 or more Exclusion Criteria: * presence of neurologic deficit * psychological or psychiatric disorder hat is expected to interfere with compliance