SUITABILITY OF A CALCIUM ALUMINATE CERAMIC IN BALLOON-KYPHOPLASTY OF OSTEOPOROTIC VERTEBRAL BODY FRACTURES. FIRST RESULTS OF A PROSPECTIVE CLINICAL TRIAL.

Abstract

Introduction: In kyphoplasty and vertebroplasty, polymethyl methacrylate (PMMA) is currently the standard in augmentation materials but it is characterized by a lack of osseointegration and limited biocompatibility. At the same time, calcium phosphate cements are not currently considered an alternative due to their insufficient mechanical stability against shear, compression and extension forces. This prospective study examines the suitability of a new calcium alumiate ceramic (Xeraspine^®, Doxa) for augmentation of vertebral fractures treated with balloon-kyphoplasty.

Methods: The operation technique follows the standard protocol for a bilateral percutaneous balloon-kypho-plasty (Kyphon). Exclusion criteria were: additional instrumentation, age > 90 years, as well as cardiac arrhythmia. The following clinical and radiological data were collected pre and post op, as well as after 6 weeks: Visual-Analogue-Score, Oswestry-Index, bisegmental endplate angle, and vertebral hight. A CT- scan was provided to show possible cement extrusion and disintegration.

Results: 20 vertebrae were included so far. The fractures could be classified as: type A1.3 (n=11), A3.1 (9). They were located at Th9 - L3. All 20 patients reported pain relief immediately post op. Restoration of endplate angles was 6,2° on average. There was no case of cement disintegration. No loss of correction was observed radiologically.

Discussion: The calcium aluminate ceramic used in balloon-kyphoplasty is an alternative to PMMA. Due to comparable shear, compression and extension strengths, there is no risk of cment breakage and following loss of correction. On the other hand the calcium aluminate ceramic shows better biocompatibility if compared to PMMA.