Dieter Mesotten.

Before medical center discharge, we quantified functional status according to the range walked in 6 mins32 and the proportion of individuals who were independent in all activities of daily living.33 We also compared both groups with respect to the total incremental health care costs from randomization to hospital discharge. Statistical Analysis The sample-size calculation was based on the ability to identify a between-group change of just one 1 day in the ICU stay with a power of at least 80 percent also to concomitantly identify a change of 3 percent in the rate of death in the ICU with a power of at least 70 percent.24 All analyses were performed on an intention-to-treat basis.Study Treatment All vertebroplasty practitioners in the trial were experienced highly, having performed a mean of around 250 procedures . Patients were brought to the fluoroscopy suite, where conscious sedation was sterile and induced preparation for surgery was performed. Using fluoroscopic guidance, the practitioner infiltrated the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1 percent lidocaine and infiltrated the periosteum of the pedicles with 0.25 percent bupivacaine. Patients were then randomly assigned to endure either the full vertebroplasty procedure or the control intervention.