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This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.
The three treatments are the following: 1/Conventional medical treatment including rest and pain medications2/Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.3/Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement may be injected with low pressure into the created cavity. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than medical treatment and vertebroplasty.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Osteoporotic Vertebral Fracture
conventional treatment, kyphoplasty with balloons, vertebroplasty
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Assistance Publique - Hôpitaux de Paris
Published on BioPortfolio: 2014-07-23T21:20:23-0400
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