Status:
COMPLETED
Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Sociedad Española de Radiologia Medica
Conditions:
Spinal Fracture
Osteoporosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared...
Detailed Description
Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients ...
Eligibility Criteria
Inclusion
- Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
- Fragility; i.e. fracture not in relation with significant trauma
- Recent fracture, pain beginning not earlier than 1 year before inclusion
Exclusion
- No vertebral edema on STIR MR images
- Uncorrectable bleeding diatheses
- Active infection
- Substantial retropulsion of bony fragments
- Non-osteoporotic fracture
- Concomitant neoplasm
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00994032
Start Date
March 1 2006
End Date
June 1 2011
Last Update
February 23 2017
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain, 08036