Contact information
Type
Scientific
Primary contact
Dr Edwin van der Linden
ORCID ID
Contact details
Department of Radiology Hs-220
Erasmus MC - University Medical Center Rotterdam
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 463 2886
e.vanderlinden@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCMO NL14746.078.07; Erasmus MC METC 2007-033
Study information
Scientific title
Acronym
VERAMM
Study hypothesis
Vertebroplasty improves the quality of life of the individual patient by increased pain reduction and restoration of mobility. Vertebroplasty also reduces costs, as it decreases the number of inpatient days, the number of outpatient visits and follow-up treatments, and the need for home care.
Ethics approval
The VERAMM trial was approved by the Medical Ethics Committee Erasmus MC (METC) on the 15th March 2007 (ref: MEC-2007-033).
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Spinal metastases, vertebroplasty, multiple myeloma
Intervention
Arm I (control): radiotherapy (20 Gy) of affected vertebrae
Arm II: vertebroplasty of affected vertebrae
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Degree of pain (VAS-pain score, scale: 0 - 10), measured at day 0 (pre-treatment), day 0 (post-treatment), day 7, week 4, week 12, month 6 and year 1
2. Use of pain medication, measured at day 0 (pre-treatment), day 0 (post-treatment), day 7, week 4, week 12, month 6 and year 1
Secondary outcome measures
1. Initial technical success and complications, measured at day 0 (post-treatment) and week 4 respectively
2. Mobility (Oswestry-daily activity scale), measured at day 0 (pre-treatment), day 7, week 4, week 12, month 6 and year 1
3. Quality of life (questionnaires: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire on Myeloma [EORTC QLQ-MY24], 36-item Short Form health survey [SF-36]), measured at day 0 (pre-treatment), day 7, week 4, week 12, month 6 and year 1
4. Collapse of treated vertebrae (lateral X-WK), measured at day 0 (pre-treatment), week 4, week 12, month 6 and year 1
5. Mortality, measured at year 1
6. Direct medical costs (e.g. procedure costs, hospitalisation days, pain medication, secondary interventions, revalidation or nursing home costs, follow-up), measured at year 1
Overall trial start date
04/06/2007
Overall trial end date
01/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Persistent pain caused by vertebral metastases from myeloma (including plasmacytoma) with Visual Analogue Scale (VAS) score greater than 4 (scale: 1-10)
2. Informed consent
3. Older than 18 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
104
Participant exclusion criteria
1. Greater than four 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 less than 30 (moribund)
Recruitment start date
04/06/2007
Recruitment end date
01/03/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Radiology Hs-220
Rotterdam
3015 CE
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Radiology
s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list