2009 Annual Meeting Podium Presentations

Spine 3: Deformity

A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Care for Vertebral Compression Fractures

Podium No: 315

Thursday, February 26, 2009
12:18 PM - 12:24 PM

Location: Venetian Hotel
Palazzo P

Jan Van Meirhaeghe, MD Oostkerke Belgium
Steven Boonen, MD Leuven Belgium
Leonard Bastian, MD Leverkusen Germany
Douglas Wardlaw FRCS Aberdeen United Kingdom

Moderator(s):
Bryan A Gunnoe, MD Grants Pass OR
Jeffrey C Wang, MD Santa Monica CA

THE FREE TRIAL IS AN INTERNATIONAL MULTICENTER RANDOMIZED COMPARISON OF BALLOON KYPHOPLASTY AND NONSURGICAL MANAGEMENT IN PATIENTS WITH ACUTE VERTEBRAL BODY COMPRESSION FRACTURES

Balloon kyphoplasty is a minimally invasive procedure performed in patients with painful vertebral fractures with the goal of reducing pain and improving quality of life. .We performed a randomized trial to assess its efficacy and safety.

Patients with acute vertebral fractures were randomly assigned to kyphoplasty (N=149) or nonsurgical care (N=151). The primary outcome was the difference in the SF-36 physical component summary at one month. Quality of life measurements and spine radiographs were assessed through twelve months.

Subjects randomized to kyphoplasty had greater improvement than controls in the SF-36 physical component summary (difference 5.2 points; 95% confidence interval [CI], 2.9'7.4; p<0.001) at one month; the difference was 1.5 (95%CI,'0.8'3.8;p=0.2) at twelve months. Kyphoplasty improved quality of life by the 1-point EuroQol questionnaire at one (0.18 points; 95%CI,0.08'0.28;p<0.001) and twelve (0.12;95%CI,0.01'0.22;p=0.025) months and back function by the 24-point Roland-Morris scale at one (4.0 points; 95%CI, 2.6'5.5; p<0.001) and twelve (2.6;95%CI,1.0'4.1;p=0.001) months. Kyphoplasty patients reported fewer days with limited activity, less back pain, less use of analgesics or walking aids. At 12 months the frequency of new vertebral fractures did not differ significantly between kyphoplasty (41.8%) and nonsurgical (37.8%) groups (4% difference; 95%CI,-7.5to 15.6;p=0.5). Two-year data will be available for analysis prior to the meeting and will be presented.

Among patients with acute vertebral fractures, balloon kyphoplasty improved quality of life, reduced back pain and disability and decreased analgesics and walking aid usage. Most of these improvements last at least one year without increasing new vertebral fractures.

A ^· to the left of the title indicates the FDA has not cleared the drug or device for the described purpose.

An alphabetical listing of disclosures will be available at a later time.

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