[Long-term efficacy and safety of balloon kyphoplasty for treatment of osteoporotic vertebral fractures].

Objective: The aim of the evaluation of treatment protocols was an extension of the documentation regarding efficacy, duration of action and safety of balloon kyphoplasty. In addition, the data analysis should be used to clarify whether differences arise concerning the treatment success, depending on the number and/or position of the augmented vertebral bodies.

Materials And Methods: The data of all patients who were admitted and operated on for vertebral body fractures between 2004 and 2009 were collected and evaluated for this study. The patients were examined pre-operatively and during the control visits clinically and radiologically. The intensity of pain was recorded on a visual analogue scale (VAS: 0-100 mm). To determine the functional limitations the Oswestry questionnaire was used. In addition, the middle and anterior heights of the vertebral body and the kyphosis angle were measured. To perform the balloon kyphoplasty the Kyphon® system was applied. The findings of all patients were documented in order to evaluate the efficacy and safety of balloon kyphoplasty for up to 3 years and to compare them with regard to the differences depending on the number and/or location of vertebral fractures (T = 1, T > 1, L = 1, L > 1, T + L).

Results: The overall evaluation of all patients (n = 464) in whom a balloon kyphoplasty was carried out showed an average improvement in VAS scores by 53 mm and the Oswestry scores by 47 percentage points. It was possible to demonstrate a significant improvement of the vertebral body height (mean 1.6 mm) and the kyphosis angle (1.3 degrees) in long-term controls up to 3 years. When comparing the findings in the groups that had been operated on a different number of vertebrae and/or at different positions in the spinal region (n = 466) it could be proven that the average decrease in pain intensity did not differ in all 5 groups (> 50 mm). Also for the Oswestry scores the reduction was almost comparable in all 5 groups. The radiological findings did not show striking differences between the 5 groups.

Conclusions: Balloon kyphoplasty was proven to be a safe and effective procedure. Thus, the balloon kyphoplasty in carefully selected patients can yield better results than a non-invasive conservative treatment. It contributes decisively a better quality of life for the operated patients and diminishes the risks of long-lasting treatment with drugs.