Dr. Steven R. Garfin of University of California, San Diego, and other members of the Balloon Kyphoplasty Outcomes Group analyzed the outcomes of 155 patients with painful spinal fractures, called vertebral compression fractures (VCFs). Most of the fractures were related to weakening of the bone caused by osteoporosis.
The patients underwent balloon kyphoplasty at 19 U.S. hospitals. In the kyphoplasty procedure, a balloon is used to line up the fragments of the fracture, then an acrylic cement is injected to hold the fragments in place. In 43 patients, two or more fractures were treated.
Before treatment, the patients had severe back pain—average score 15 on a 20-point scale. The spinal fractures were causing major problems with physical functioning and quality of life, including inability to perform normal daily activities.
Balloon kyphoplasty was followed by "rapid, marked, and sustained pain reduction and functional improvement," the researchers write. Within a week after treatment, the average pain score dropped from 15 to 6. The reduction in pain remained significant at 2 years' follow-up.
Treatment also produced lasting improvement in functioning, including fewer days in bed and fewer days with activity limitations. Patients also had long-term improvement in most areas of quality of life, including physical and social activities. About 60 percent of patients rated themselves "completely satisfied" with their treatment results. Good results were achieved even with VCFs that had been present for longer than two months.
There were few complications of kyphoplasty. Nearly one-fourth of patients developed a new fracture within two years—the study provided no data to determine whether this risk was higher, lower, or the same as it would have been without kyphoplasty.
Vertebral compression fractures are a major problem for patients with osteoporosis, causing pain, reduced physical and mental health, and reduced quality of life.
Kyphoplasty is a relatively new, minimally invasive treatment for this type of spinal fracture. Although results have been generally encouraging, most studies so far have included only short-term results.
The new results "provide good evidence that balloon kyphoplasty provides both rapid and long-lasting improvements clinically and functionally," the authors conclude. Patients have rapid improvement in pain, functional ability, and quality of life, which are still present two years later. The procedure appears safe and produces high patient satisfaction rates. Although continued research is needed, "balloon kyphoplasty should be considered...for older patients diagnosed with a painful VCF," the researchers believe.