A prospective study of percutaneous balloon kyphoplasty with calcium phosphate cement in traumatic vertebral fractures: 10-year results.

STUDY
DESIGN: This is a prospective study to investigate the clinical and radiological results 10 years after percutaneous balloon kyphoplasty and cement augmentation with calcium phosphate cement (CPC) in traumatic vertebral fractures type A.
OBJECTIVES: Evaluation of a 10-year follow-up with radiological and computed tomography results, calculated by 2 independent radiologists, VAS, Roland Morris score, Oswestry Disability Index (ODI) score and Denis work scale and clinical examination in patients with traumatic compression fractures type A, who were treated with a balloon kyphoplasty with CPC (Calcibon™ from Biomed).
METHODS: In this study, we evaluated 21 patients (8 female and 13 male) clinically and radiologically 10 years postoperative and compared them with the same group of 28 patients we operated between August 2002 and August 2003 for traumatic vertebral fractures type A with balloon kyphoplasty and CPC. Over the 10 years, 7 patients were lost to follow-up. 3 of them were not clinically impaired but did not want to participate in the study and 4 patients were untraceable. All 21 patients underwent standard X-ray (standing) and a CT. We measured the volume of the cement, the resorption the last 10 years and the disc height in the CT and the segmental and vertebral kyphosis angle in the X-ray and compared them with the X-ray (standing) and CT done directly postoperatively. To assess the pain level we used the VAS, ODI score, Roland Morris score and the Denis work scale and compared them with the same scores we recorded in the past.
RESULTS: The VAS score demonstrated an increase over time from a mean of 1 (0-5) at the 2-year follow-up to 2.3 (0-8) at the 10-year follow-up. The Roland Morris disability score also increased over time from 2 (0-8) 2 years postoperative to a mean of 3.6 (0-18) at the 10 years follow-up. We recognized no complications and no reoperations were necessary. We recognized an increase of the median value for the vertebral kyphosis angle about 1° (0°-4°) (p < 0.0001). The median value of the disc height diminution over the 10 years was 0.7 mm (0-3.9) (p < 0.0001). For the anterior wall of the fractured VB the decrease of the median value was about 1 mm (0-3) (p < 0.0001) and for the posterior wall it was 0 mm (0-2) (p < 0.0039). So the beck index decreased from 0.80 (0.65-0.97) to 0.77 (0.62-0.97) at the 10-year follow-up, which means a decrease of the median value of 0.03 (0-0.07) (p < 0.0039). We noticed a median value for the cement volume of 4.2 cc (2.0-8.6) postoperative and at the 10-year follow-up of 3.2 cc (1.3-7.8), which means a resorption of the cement volume about 22.9 % (0.8-55.5 %) (p < 0.0001).
CONCLUSIONS: In our 10-year follow-up, we did not recognize any high loss of correction of the vertebral and segmental kyphosis angle. We also did not recognize a high diminution of the disc height without degeneration of the disc over the last 10 years. There was a partial resorption of the cement but not as much as we expected with variable bone formation. In summary, the long follow-up about 10 years of kyphoplasty show us very good clinical and radiological results and in our opinion we consider this to be a treatment option for traumatic selected vertebral type A fractures also in young patients.