The Journal of Bone and Joint Surgery (American). 2009;91:2747.
doi:10.2106/JBJS.9111.ebo890
© 2009 The Journal of Bone and Joint Surgery, Inc.
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Evidence-Based Orthopaedics

Balloon Kyphoplasty Was Effective and Safe for Vertebral Compression Fractures Compared with Nonsurgical Care

Wardlaw, D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-Surgical Care for Vertebral Compression Fracture (FREE): A Randomised Controlled Trial. Lancet. 2009 Mar 21;373:1016-24.[CrossRef][Medline]

The first 20% of the full text of this article appears below.

Question: In patients with acute vertebral compression fractures, is balloon kyphoplasty more effective than nonsurgical care?

Design: Randomized (allocation concealed)*, unblinded, controlled trial with up to 12 months of follow-up (Fracture Reduction Evaluation [FREE] trial).

Setting: 21 sites in 8 countries (Austria, Belgium, France, Germany, Italy, The Netherlands, Sweden, and the United Kingdom).

Patients: 300 patients who were ≥21 years of age (mean age, 73 y; 77% women) had 1 to 3 vertebral fractures from T5 through L5, with ≥1 fracture showing edema on magnetic resonance imaging and ≥1 showing a 15% loss of height, and a back pain score ≥4 on a scale of 0 to 10. Patients with . . . [Full Text of this Article]

David Cohen, MD

Johns Hopkins University, Baltimore, Maryland


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