Percutaneous Vertebroplasty Versus Conservative Treatment of Pain
Not Applicable
Completed
- Conditions
- PainOsteoporosisFracture
- Registration Number
- NCT00203554
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Level of pain before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Dep of Neuroradiology, Aarhus University Hospital
🇩🇰Aarhus, Denmark