Prompt Pain Relief for Compression Fractures with Balloon Kyphoplasty

MILAN—Painful vertebral compression fractures can be promptly and effectively treated with balloon kyphoplasty, an international study showed.

The Cancer Patient Fracture Evaluation (CAFE) study was the first to randomize cancer patients with vertebral compression fractures to balloon kyphoplasty or standard nonsurgical treatment (controls). The results were reported by Leonard Bastian, MD, of the Klinikum Leverkusen in Leverkusen, Germany.

“We found that we can reduce pain immediately in these patients,” Bastian said at a press conference. “Cancer patients with vertebral compression fractures having balloon kyphoplasty have a superior outcome.”

Balloon kyphoplasty involves a 1-cm incision into the fractured vertebra through which a balloon is inserted and inflated to restore the shape and height of the vertebra. The balloon is then deflated and removed, and quick-setting bone cement is injected into the vertebral body to maintain the shape.

The study population included 134 patients with three or fewer vertebral compression fractures who were randomized to kyphoplasty (n = 70) or nonsurgical management (n = 64), mainly physical therapy, analgesics, and sometimes braces and bed rest. Patients were followed for 1 year.

After 1 month, the Roland-Morris Disability Questionnaire score dropped by 8.3 points in the kyphoplasty group but increased slightly by 0.1 point in the nonsurgical group. After just 1 week, the kyphoplasty group reported significant improvements in back pain, with a change in the numerical rating scale of -3.8 points, compared with virtually no change in the control group, and they used less analgesia.

The difference between the groups in the two pain measurements was highly significant (P <.0001), Bastian noted.

Patients receiving balloon kyphoplasty reported significantly fewer days with limited activity—6.2 days fewer per 2 weeks (P <.0001)—and greater im - provements in quality of life as mea - sured by an eight-point advantage in the SF-36 score (P <.0001).

Crossover to kyphoplasty was allowed after 1 month, and the 38 patients who did so experienced similar benefits with regard to back pain relief, activity level, and quality of life.

“All the balloon kyphoplasty patients reported sustained improvements throughout the 12-month period of the study,” Bastian said.

Adverse events were similar except for the occurrence of one intraoperative non–Q-wave myocardial infarction that resolved in the kyphoplasty group and a cement leakage to the disc and adjacent fracture 1 day later in another patient.

The indication for this procedure is virtually any painful vertebral compression fracture or multiple fractures. Bones that have been highly compromised due to metastases, however, may not be amenable to kyphoplasty.