Medtronic has presented the results of the first randomized, controlled trial comparing Kyphon Balloon Kyphoplasty with non-surgical care in treating spinal fractures in cancer patients.
The Cancer Patient Fracture Evaluation (CAFE) study, sponsored by the Kyphon Products Division of Medtronic, involved 134 patients with vertebral compression fractures who also had various types of cancer such as breast, lung, and prostate or had multiple myeloma.
The study took place at 22 sites in the US, Europe, Australia and Canada and the patients were randomized to either a Kyphon Balloon Kyphoplasty group (n=70) or a non-surgical control group (n=64).
Members of both groups were able to receive non-surgical care, such as pain medications, best rest, bracing, walking aids and radiation therapy, as medically appropriate.
The study found that Kyphon Balloon Kyphoplasty provided cancer patients better back-specific function, more rapid back pain relief and improved quality of life compared with non-surgical care one month after treatment.