Fracture, Osteoporosis, Pain
Conditions
Keywords
osteoporosis, vertebra, fracture, pain, percutaneous, vertebroplasty, polymethylmetacrylate
Brief summary
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.
Detailed 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.
Interventions
GENETICPoly methylmetacrylate, PMMA
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of pain | before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Needs for analgetics, number of days at hospital, level of ADL | before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. |
Countries
Denmark
Outcome results
None listed