Percutaneous Vertebroplasty Versus Conservative Treatment of Pain
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.
Full description
In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.
The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.
Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.
Enrollment
Sex
Volunteers
Inclusion criteria
- new pain in spine (within 6 months)
- x-ray verified low energy spinal fracture(s)
Exclusion criteria
- less than 20% or more than 90% reduction of the vertebral height
- lack of pain at fracture level
- no need for continuous analgesic treatment
- patient no able to communicate
- general anaesthesia contraindicated
- MRI not possible
- coagulopathy (not adjustable)
- spondylitis
- discitis
- spinal metastasis
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal