Vertebroplasty versus radiotherapy as palliative treatment of vertebral metastases of multiple myeloma (M. Kahler)
Recruiting
- Conditions
- VertebroplastySpinal metastasesMultiple myelomaVertebroplastiekwervellokatiesmultipel myeloom
- Registration Number
- NL-OMON25306
- Lead Sponsor
- Erasmus MC — University Medical Center Rotterdam, the NetherlandsInvestigator Initiated Study)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 104
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
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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Degree of pain (VAS-pain score, scale: 0-10; pre-treatment and first 7 days post procedure);<br>2. Use of pain medication (pretreatment and day 0,day 7, week 4, week 12, month 6, year 1 after treatment)<br>
- Secondary Outcome Measures
Name Time Method 1. Initial technical success & complications<br>Mobility (Oswestry-daily activity scale);<br>2. Quality of life (questionnaires:EORTC QLQ-MY24, SF-36);<br>3. Collapse of treated vertebrae (lateral X-WK)<br>4. Mortality<br>5. Direct medical costs (e.g. procedure costs, hospitalisation days, pain medication, secondary interventions, revalidation or nursing home costs, follow-up)<br>