Is there an indication for prophylactic balloon kyphoplasty? A pilot study.

Vertebroplasty and kyphoplasty are associated with a recurrent fracture rate of 2.4% to 23%, which is lower than the general natural history of untreated osteoporotic fractures. Some authors suggest the risk of refracture at adjacent vertebra will be reduced by prophylactic stabilization. We therefore compared the refracture rate after prophylactic balloon kyphoplasty in 60 patients randomized into groups with either monosegmental balloon kyphoplasty or adjacent prophylactic balloon kyphoplasty. The level (superior versus inferior) for prophylactic stabilization was chosen according to fracture type. We evaluated patients for 12 months using radiographs, visual analog scale scores, and SF-36 scores. We followed 23 of 30 patients in the monosegmental group and 27 of 30 patients in the prophylactic group. We observed no difference in the 1-year refracture rates between the two groups (five patients in the monosegmental group and seven in the prophylactic group). Leakage into the disc was the presumed cause of adjacent fractures in 50% of the patients. Disc leakage and refracture rate did not correlate as a result of the low patient number. Based on our data, we believe there is no indication for prophylactic stabilization of adjacent segments with balloon kyphoplasty.

RCT Entities:   Population Interventions Outcomes