Vertebroplasty Spinal metastases Multiple myeloma Vertebroplastiek wervellokaties multipel myeloom
Conditions
Interventions
Arm I (control):
radiotherapy (20 Gy) of affected vertebrae
Arm II:
vertebroplasty of affected vertebrae
Sponsors
Erasmus MC — University Medical Center Rotterdam, the Netherlands
Investigator Initiated Study)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Persistent pain caused by vertebral metastases from myeloma (including plasmacytoma) with VAS score >4 (scale: 1-10); 2. Informed consent; 3. Older than 18 years;
Exclusion criteria
Exclusion criteria: 1. >4 affected vertebrae; 2. Vertebral fracture through back wall with retropulsion that consumes more than 33% of the spinal channel; 3. Myelum compression with neurological degeneration: Frankel A/B; 4. Epiduritis; 5. Incorrigible coagulopathy; 6. Karnofsky score <30 (moribund);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Degree of pain (VAS-pain score, scale: 0-10; pre-treatment and first 7 days post procedure); 2. Use of pain medication (pretreatment and day 0,day 7, week 4, week 12, month 6, year 1 after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Initial technical success & complications Mobility (Oswestry-daily activity scale); 2. Quality of life (questionnaires:EORTC QLQ-MY24, SF-36); 3. Collapse of treated vertebrae (lateral X-WK) 4. Mortality 5. Direct medical costs (e.g. procedure costs, hospitalisation days, pain medication, secondary interventions, revalidation or nursing home costs, follow-up) | — |
Contacts
Public ContactResearch Office, Erasmus MC Dept of Radiology
Research Office Erasmus MC Dept of Radiology ‘s Gravendijkwal 230
Outcome results
None listed