Quality of life improved with kyphoplasty

Pain scores decreased, ambulatory status increased with the procedure; long-term follow-up data needed.

Issue: Issue 6 2003

EuroSpine [logo] PRAGUE — One-year outcomes in a 155-patient trial indicated that kyphoplasty was safe and effective, and improved physical and emotional health of the patients.

In two presentations at EuroSpine 2003, here, Jon T. Ledlie, MD, said that the new procedure not only can improve quality of life but also can reduce pain for patients with vertebral compression fractures. “Kyphoplasty offers the only treatment that can reduce and internally fix vertebral compression fractures in a minimally invasive way.” Ledlie is affiliated with Tyler Neurosurgical Associates in Tyler,U.S.A.

Kyphoplasty includes the insertion of a balloon into the fractured vertebral body. The balloon, or tamp, is then inflated to restore height to the bone. Once the balloon is withdrawn, a bone filler — PMMA or polymethylmethacrylate bone cement is the usual choice in the United States — is introduced into the vertebral body and the procedure is completed.

Ledlie cited a World Health Organization statistic that vertebral compression fractures are second only to cardiovascular disease in their health impact and are generally the result of osteoporosis. Forty-percent of middle-aged women and 15% of middle-aged men in Europe will experience at least one osteoporotic fracture in their lifetime.

The prospective, single-arm, multicenter study, the topic of Ledlie’s first presentation, included patients with long-term pain; mean duration of pain before surgery was 129 days. Eight-one percent of patients were women; average age was 77. All patients were given general anesthesia.

Conducted under Institutional Review Board approval, the Kyphoplasty Study Group trial focused on safety, SF-36 scores and patient satisfaction. All adverse effects were documented. Nine percent of cases had cement extravasations but none were clinically significant. There were 100 adverse effects that were all related to patient comorbidity, with many of those attributed to constipation.

SF-36 scores improved significantly, Ledlie said. Both physical and mental composite summaries increased approximately 14 points. A six- to seven-point increase is considered statistically significant, he said. Eighty percent of patients had at least 10% of height restored.

Radiographic results

The second presentation included the two-year radiographic and clinical results of 126 consecutive kyphoplasty procedures (117 patients) performed at Ledlie’s institution in Texas. Mean age of patients was 76 and 72% were women. Mean hospital stay was 1.2 days.

Average pain score of patients was 8.8 preop and 2.2 one-week postop and continued to decrease over the two years postop. Ambulatory status also increased: 30% of patients were not ambulatory prior to surgery; all were ambulatory by one year.

Vertebral height was increased by the procedure at one week, a statistically significant change. Seventy percent of patients had at least a 20% increase in height, Ledlie said.

For your information:

Garfin SG, Ledlie JT, Kyphoplasty Study Group. #2. Continuing significant improvement in physical and emotional health following kyphoplasty for painful pathological vertebral body compression fractures (VCFs): one year outcomes from an IRB-approved, prospective, single arm, multi-center, prospective study.

Ledlie JT. #4. Two-year radiographic and clinical results from kyphoplasty: a minimally invasive treatment for painful vertebral compression fractures. Both presented at 5th Annual Meeting of the Spine Society of Europe. Oct. 1-4, 2003. Prague.