Patient safety in surgery

BACKGROUND: Kyphoplasty represents an established minimal-invasive method for correction and augmentation of osteoporotic vertebral fractures. Reliable data on perioperative and postoperative complications are lacking in the literature. The present study was designed to evaluate the incidence and patterns of perioperative complications in order to determine the safety of this procedure for patients undergoing kyphoplasty. PATIENTS AND METHODS: We prospectively enrolled 102 consecutive patients (82 women and 20 men; mean age 69) with 135 operatively treated fractured vertebrae who underwent a kyphoplasty between January 2004 to June 2006. Clinical and radiological follow-up was performed for up 6 months after surgery. RESULTS: Preoperative pain levels, as determined by the visual analogous scale (VAS) were 7.5 +/- 1.3. Postoperative pain levels were significantly reduced at day 1 after surgery (VAS 2.3 +/- 2.2) and at 6-month follow-up (VAS 1.4 +/- 0.9). Fresh vertebral fractures at adjacent levels were detected radiographically in 8 patients within 6 months. Two patients had a loss of reduction with subsequent sintering of the operated vertebrae and secondary spinal stenosis. Accidental cement extravasation was detected in 7 patients in the intraoperative radiographs. One patient developed a postoperative infected spondylitis at the operated level, which was treated by anterior corporectomy and 360 degrees fusion. Another patient developed a superficial wound infection which required surgical revision. Postoperative bleeding resulting in a subcutaneous haematoma evacuation was seen in one patient. CONCLUSION: The data from the present study imply that percutaneous kyphoplasty can be associated with severe intra- and postoperative complications. This minimal-invasive surgical procedure should therefore be performed exclusively by spine surgeons who have the capability of managing perioperative complications.