Preliminary clinical outcomes of percutaneous kyphoplasty with Sky-bone expander.

BACKGROUND

Percutaneous kyphoplasty (PKP) using balloon expander has been proved to be effective in the treatment of painful vertebral compression fractures. Recently, Sky-bone expander, an alternative bone expander for PKP has been developed. The purpose of this study was to show our preliminary clinical outcomes of PKP with Sky-bone expander.

METHODS

PKP with Sky-bone expander was performed in 25 patients (30 vertebrae). The operation time, bleeding volume, cement volume injected were recorded. The pain and functional activities of the patients before and after the operation were compared using Wilcoxon signed-rank test. The cement distribution in the vertebrae, vertebral height restoration, and kyphosis correction after the procedure were evaluated by radiography. The pre- and post-operative absolute values of the vertebral height and kyphotic angle were compared by paired-sample t test. All the patients were followed up by telephone or clinic consulting after being discharged from our hospital.

RESULTS

The procedure was performed successfully in all the patients. Bipedicular injection was used in 2 of the patients, and unipedicular injection was made in the others. The operation time ranged from 25 to 120 minutes (45 minutes per vertebra on average). The average bleeding volume was about 20 ml. Polymethylmethacrylate 1.5-5.0 ml (mean, (3.15+/-0.78) ml) was injected through each pedicle into all the patients except one, who received calcium sulphate 3.5 ml instead. The patients were followed up for 12-15 months (13.5 months on average). The mean visual analogue scale (VAS) score, Oswestry Disability Index, anterior, midline, and posterior vertebral height, and kyphotic angle of the patients were improved significantly at the end of the follow-up compared with those before the operation. (2.5+/-1.3, 35.1%, (20.94+/-6.15) mm, (20.26+/-4.59) mm, (26.72+/-3.49) mm, and 8.2 degrees vs. 8.5+/-1.9, 61.2%, (19.11+/-6.72) mm, (15.88+/-5.73) mm, (25.78+/-3.67) mm, and 17.3 degrees; all P<0.05). The cement distribution with unipedicular injection was mostly limited within the injection site in the vertebral body. Cement extravasation was seen at ten levels (33.3%).

CONCLUSIONS

PKP with Sky-bone expander is an effective and relatively safe alternative to the PKP using balloon expander. It can relieve pain, improve physical function, and restore the height of the collapsed vertebrae, but the cement extravasation is unsolved.