• Jan Van Meirhaeghe, Leonard Bastian, Steven Boonen, Jonas Ranstam, John B Tillman, Douglas Wardlaw, and FREE investigators.
• *Dienst Orthopedie en Traumatologie, Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV, Brugge, Belgium †Klinikum Leverkusen, Leverkusen, Germany ‡Leuven University Division of Geriatric Medicine, KU Leuven, Leuven, Belgium §Swedish National Competence Centre for Musculoskeletal Disorders at Lund University Hospital, Lund, Sweden ¶Medtronic Inc., Sunnyvale, CA; and ‖Orthopaedic Department, Woodend Hospital, NHS Grampian, Aberdeen, UK.
• Spine. 2013 May 20;38(12):971-83.

Study DesignMulticenter randomized controlled trial.ObjectiveTo compare the efficacy and safety of balloon kyphoplasty (BKP) with nonsurgical management (NSM) during 24 months in patients with painful vertebral compression fractures (VCFs).Summary Of Background DataRecently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographical vertebral deformity results.MethodsAdults with 1 to 3 VCFs were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life assessments and objective functional (timed up and go) and radiographical assessments were collected.ResultsCompared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at 1 month (5.35 points; 95% CI, 3.41-7.30; P < 0.0001) and when averaged across the 24 months (overall treatment effect 2.71 points; 95% CI, 1.34-4.09; P = 0.0001). The kyphoplasty group also had greater functionality by assessing timed up and go (overall treatment effect -2.49 s; 95% CI, -0.82 to -4.15; P = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.13° of correction for kyphoplasty compared with 0.82° in the control, P = 0.003). Number of baseline prevalent fractures (P = 0.0003) and treatment assignment (P = 0.004) are the most predictive variables for PCS improvement; however, in patients who underwent BKP, there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) than the quart having lowest correction of angulation (7.40 points, P = 0.0146 for difference). The most common adverse events temporally related to surgery (i.e., within 30 d) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM), and urinary tract infection (10 BKP, 3 NSM). Several other adverse events were possibly related to patient positioning in the operating room.ConclusionCompared with NSM, BKP improves patient quality of life and pain averaged during 24 months and results in better improvement of index vertebral body kyphotic angulation. Perioperative complications may be reduced with more care in patient positioning.Level Of Evidence2.

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