Abstract
BACKGROUND
As life expectancy in the population rises, osteoporotic fractures are seen most frequently in the vertebral column. Percutaneous kyphoplasty is increasingly used for pain reduction and stabilization in these patients, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain.
OBJECTIVE
To clarify whether kyphoplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.
MATERIALS & METHODS
From January 2004 to June 2009, 122 patients (31 males and 91 females), from 56 to 85 years old (mean age 68.5) were treated for 165 osteoporotic vertebral fractures of the thoracic or lumbar spine (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Twelve patients (15 fractures) were lost at follow-up period and excluded. Patients were randomly allocated to percutaneous kyphoplasty (75 patients) or conservative treatment by computer-generated randomization codes. All fractures were analyzed for improvement in sagittal alignment (Cobb angle, kyphotic angle, sagittal index, vertebral height); and pain relief at 1, 6, 12, 24 months, as measured by VAS score.
RESULTS
Percutaneous kyphoplasty resulted in direct and greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was −6,5 after kyphoplasty and −2.4 after conservative treatment, and between baseline and 1 year was −7.2 after kyphoplasty and −3.8 after conservative treatment. No serious complications or adverse events were reported. Apart from the pain, the patient's ability to ambulate independently and without difficulty, and the need for medications improved significantly (P < 0.001) after kyphoplasty. Vertebral height significantly increased at all postoperative intervals, with 10% height increases in 88% of fractures, in kyphoplasty group at 2 years. There were no severe kyphoplasty-related complications, such as neurological defects, cement leakage or narrowing of the spinal canal whereas additional fractures occurred at the adjacent vertebrae at a rate of 10%. 35% of patients treated conservatively, had limitations in everyday activities the first 6 months, whereas additional fractures occurred at the adjacent vertebrae at a rate of 14%.
CONCLUSION
In patients with acute osteoporotic vertebral compression fractures and persistent pain, balloon kyphoplasty is effective and safe. Pain relief after kyphoplasty is immediate, is sustained for at least 2 years, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.
