Temperature measurement during polymerization of bone cement in percutaneous vertebroplasty: an in vivo study in humans.

Aim of the study was to "in vivo" measure temperature, during percutaneous vertebroplasty (PV), within a vertebral body injected with different bone cements. According to the declaration of Helsinki, 22 women (60-80 years; mean, 75 years) with painful osteoporotic vertebral collapse underwent bilateral transpedicular PV on 22 lumbar vertebrae. Two 10-G vertebroplasty needles were introduced into the vertebra under digital fluoroscopy; a 16-G radiofrequency thermoablation needle (Starburst XL; RITA Medical System Inc., USA), carrying five thermocouples, was than coaxially inserted. Eleven different bone cements were injected and temperatures were measured every 30 s until temperatures dropped under 45 degrees C. After the thermocouple needle was withdrawn, bilateral PV was completed with cement injection through the vertebroplasty needle. Unpaired Student's t-tests, Kruskal-Wallis test, and Wilcoxon signed rank test were used to evaluate significant differences (p < 0.05) in peak temperatures, variations between cements, and clinical outcome. All procedures were completed without complications, achieving good clinical outcomes (p < 0.0001). Regarding average peak temperature, cements were divided into three groups: A (over 60 degrees C), B (from 50 degrees to 60 degrees C), and C (below 50 degrees C). Peak temperature in Group A (86.7 +/- 10.7 degrees C) was significantly higher (p = 0.0172) than that in Groups B (60.5 +/- 3.7 degrees C) and C (44.8 +/- 2.6 degrees C). The average of all thermocouples showed an extremely significant difference (p = 0.0002) between groups. None of the tested cements maintained a temperature >or=45 degrees C for more than 30 min. These data suggest that back-pain improvement is obtained not by thermal necrosis but by mechanical consolidation only. The relative necrotic thermal effect in vertebral metastases seems to confirm that analgesia must be considered the main intent of PV.