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Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures

2014-07-23 21:20:23 | BioPortfolio

Summary

This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.

Description

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.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Osteoporotic Vertebral Fracture

Intervention

conventional treatment, kyphoplasty with balloons, vertebroplasty

Location

Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris
France
75010

Status

Recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:20:23-0400

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Medical and Biotech [MESH] Definitions

Procedures to repair or stabilize vertebral fractures, especially compression fractures by injecting BONE CEMENTS into the fractured VERTEBRAE.

Procedures to restore vertebrae to their original shape following vertebral compression fractures by inflating a balloon inserted into the vertebrae, followed by removal of the balloon and injection of BONE CEMENTS to fill the cavity.

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