Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery.

Total disc replacement for chronic back pain in the presence of disc degeneration (Review)

Purpose. To compare efficacy of balloon kyphoplasty in restoring vertebral height and correcting kyphosis in patients having vertebra plana with or without osteonecrosis. Methods. 12 women and 3 men (mean age, 76 years), who had a complete vertebra plana with or without osteonecrosis (n=8 vs n=7), underwent balloon kyphoplasty. No external manoeuvres were performed before or during balloon kyphoplasty, except for positioning the patients in a prone posture on the operating table. The anterior, middle, and posterior vertebral height and the kyphotic angle were measured pre-and post-operatively with a digital imaging system. The vertebral height was measured as a percentage of the adjacent normal vertebral height. Results. Respectively in vertebra plana patients with or without osteonecrosis, the mean corrections of (1) kyphosis were 10º and 4º (p=0.099), (2) anterior vertebral height were 33% and 5% (p<0.001), (3) middle vertebral height were 38% and 18% (p=0.004), and (4) posterior vertebral height were 19% and 2% (p=0.031).

Age itself cannot be considered a contraindication.

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.