Compare vertebroplasty with radiotherapy regarding costs and effectivity in treating pain, restoring mobility, and improving quality of life.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Degree of pain reduction. Additionally initial technical success,
complications, quality of life, mortality, and costs.
Secondary outcome
Not applicable
Background summary
As the current anti-tumor treatment extends the life of M. Kahler (multiple
myeloma) patients, palliative treatment of the vertebral metastases is becoming
more important as these frequently induce invalidating pain and cause patients
to become bed-ridden. The standard treatment fo these metastases is
radiotherapy, which reduces the pain in less than 50% of patients and which is
often temporary even in the patients in which it works. Furthermore,
radiotherapy is ineffective in stabilizing affected vertebrae. The
recently-introduced treatment Vertebroplasty appears more effective: in
initial tests, vertebroplasty gave lengthy (permanent) pain reduction in 80-90%
of the patients. As vertebroplasty also stabilizes the treated vertebrae, it
gives additional benefits such as immediate recovery of mobility and long-term
prevention of pathological disintegration of vertebrae and neurological
degeneration.
Study objective
Compare vertebroplasty with radiotherapy regarding costs and effectivity in
treating pain, restoring mobility, and improving quality of life.
Study design
RCT
Intervention
The control group will receive the standard treatment, radiotherapy. The
experimental group will receive vertebroplasty of the affected vertebrae * the
vertebrae will be filled with bone cement via a hollow needle.
Study burden and risks
The most important complication of vertebroplasty is leakage of cement during
injection; however, this has occurred in <1% of the procedures already
performed by the COORDINATING INVESTIGATOR. Lung embolism caused by cement in
the venous circulation occurs in 2-5% of the procedures, but in not generally
associated with clinical symptoms.
Vertebroplasty is expected to improve the quality of life of the individual
test subject by increased pain reduction and restoration of mobility. We also
expect that vertebroplasty will reduce costs, in that we expect it will
decrease the number of inpatient days, the number of outpatient visits and
follow-up treatments, and the need for home care.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14746.078.07 |