Prospective study of standalone balloon kyphoplasty with calcium phosphate cement augmentation in traumatic fractures

Abstract

Prospective consecutive series cases study to investigate the clinical and radiological results of standalone balloon kyphoplasty and cement augmentation with calcium phosphate in traumatic fractures. Independent observer evaluation of radiological and computer tomography results, visual analogue scale (VAS), Roland-Morris score and complications with acute traumatic compression fractures type A, treated with a standalone balloon kyphoplasty and cement augmentation with calcium phosphate (Calcibon); follow-up time at a mean of 30 months (24-37 months). From August 2002 to August 2003, consecutive patients with traumatic compression fractures (Magerl type A) without neurological deficit underwent standalone kyphoplasty with Calcibon. We report here the pre-, post-operative and the follow-up results, applying the VAS (0-10) for pain rating, the Roland-Morris (0-24) disability score, CT-scan examination, detailed radiographic evaluation of vertebral body (VB) deformity and segmental kyphosis measurement. The pre-operative X-ray measurements, VAS and the 7 days Roland-Morris scores are compared with the post-operative and the 30 months follow-up findings. Twenty-eight patients with 33 treated fracture levels were included in this study. The mean initial vertebral deformity (VB kyphosis) was 17 degrees, corrected to a post-operative of 6 degrees. We noted a loss of correction at the follow-up in comparison to the post-operative standing X-ray at 24 h of 3 degrees vertebral deformity and 3 degrees segmental kyphosis. The VAS score demonstrates a decrease over time from a mean of 8.7-3.1 at 7 days and to 0.8 at the last follow-up. The Roland-Morris disability score demonstrates a similar improvement. We noticed no major complications related to the procedure. The mean cement resorption after 1 year was 20.3% (0.3-35.3%) and is related to the individual biological resorption process and is not predictable. All patients with vertebral fractures as sole medical problem were discharged within 48 h. All active patients returned to the same work within 3 months with the same working ability as before the accident. Standalone balloon kyphoplasty is a potential alternative mini-invasive technique to reduce the fractures. However, due to the intrinsic characteristic of calcium phosphate cement (Calcibon) we recommend the application of this biological cement for standalone reduction and stabilisation only in fractures type A1 and A3.1 in young patient. In case of higher destruction levels of the VB, we propose the utilisation of Calcibon associated with posterior instrumentation. Having regard to the pointed out indications, our preliminary results demonstrate a new possibility to treat this kind of fractures, allowing a rapid handling of pain, early discharge and return to normal activities.

Fig. 1

Twenty-six-year-old patient with L1-fracture type A3.2 after car accident

Fig. 2

Pre-operative CT-scan

Fig. 3

Pre-operative reduction of the fracture with the IBT balloons

Fig. 4

Post-operative standing X-rays at 24 h (a), 1 year (b) and 3 years (c)

Fig. 5

Post-operative CT-scan at 24 h (a), 1 year (b) and 3 years (c) of an A3.2 fracture

Fig. 6

Image of new bone formation (osteoid, osteoblasts, bone matrix, cartilage, etc.), no inflammation or necrosis in the histology of a biopsy taken 6-month post-operative—H.E. staining—magnification 24–68×