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Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation

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

Summary

Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.

Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.

Description

Patients with traumatic vertebral fractures type A3.2, A3.3, B1 and C1 of the MAGERL classification will be enrolled in this open study. They will be operated on in emergency to perform spinal canal decompression, fracture reduction and posterior fixation using fixation plates with pedicular screws combined with bone graft.

During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength.Patients will be followed up for one year.

Expected advantages of this management compared the conventional two session surgery include the following:

- decreased morbidity due to suppression of the anterior surgery

- improve final spine alignment and vertebral Kyphotic angle avoiding the loss in kyphotic angle which often occurs between the posterior and anterior surgery with the conventional two session surgery.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

One or Two Traumatic Vertebral Fractures

Intervention

balloon kyphoplasty

Location

Service de Radiologie, Hôpital Lariboisière
Paris
France
75010

Status

Terminated

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 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.

Crumbling or smashing of cancellous BONE by forces acting parallel to the long axis of bone. It is applied particularly to vertebral body fractures (SPINAL FRACTURES). (Blauvelt and Nelson, A Manual of Orthopedic Terminology, 1994, p4)

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

Traumatic or other damage to teeth including fractures (TOOTH FRACTURES) or displacements (TOOTH LUXATION).

The use of balloon CATHETERS to remove emboli by retraction of the balloon that is inflated behind the EMBOLUS.

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