Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
Not Applicable
Suspended
- Conditions
- OsteoporosisVertebral Fracture
- Interventions
- Procedure: Percutaneous vertebroplasty
- Registration Number
- NCT00635297
- Lead Sponsor
- Ullevaal University Hospital
- Brief Summary
Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.
The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.
Exclusion Criteria
- Infection
- High grade spinal stenosis
- Contraindications to MRI
- Dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Percutaneous vertebroplasty 50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty 2 Percutaneous vertebroplasty 50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty. The adjacent vertebrae will be treated with 3-5 ml of PMMA
- Primary Outcome Measures
Name Time Method Refracture rate based on MRI and CT after 3 months and one year 3 months and one year
- Secondary Outcome Measures
Name Time Method Pain relief after the procedure based on VAS 3 months and one year
Trial Locations
- Locations (1)
Nevroradiologisk avdeling Ullevål universitetssykehus HF
🇳🇴Oslo, Norway