Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis

Abstract

Previously, we reported significantly reduced pain and improved mobility persisting for 6 months after kyphoplasty of chronically painful osteoporotic vertebral fractures in the first prospective controlled trial. Since improvement of spinal biomechanics by restoration of vertebral morphology may affect the incidence of fracture, long-term clinical benefit and thereby cost-effectiveness, here we extend our previous work to assess occurrence of new vertebral fractures and clinical parameters 1 year after kyphoplasty compared with a conservatively treated control group. Sixty patients with osteoporotic vertebral fractures due to primary osteoporosis were included: 40 patients were treated with kyphoplasty, 20 served as controls. All patients received standard medical treatment. Morphological characteristics, new vertebral fractures, pain (visual analog scale), physical function [European Vertebral Osteoporosis Study (EVOS) score] (range 0-100 each) and back-pain-related doctors' visits were re-assessed 12 months after kyphoplasty. There were significantly fewer patients with new vertebral fractures of the thoracic and lumbar spine, after 12-months, in the kyphoplasty group than in the control group (P=0.0084). Pain scores improved from 26.2 to 44.4 in the kyphoplasty group and changed from 33.6 to 34.3 in the control group (P=0.008). Kyphoplasty treated patients required a mean of 5.3 back-pain-related doctors' visits per patient compared with 11.6 in the control group during 12 months follow-up (P=0.006). Kyphoplasty as an addition to medical treatment and when performed in appropriately selected patients by an interdisciplinary team persistently improves pain and reduces occurrence of new vertebral fractures and healthcare utilization for at least 12 months in individuals with primary osteoporosis.

Comparison of 5766 Vertebral Compression Fractures Treated With or Without Kyphoplasty

“…The data suggest kyphoplasty leads to more rapid return of independent functional mobility at a low risk of complications compared with nonoperative care. In contrast to recent reports questioning the efficacy of vertebral augmentation [4,34], our results support the use of kyphoplasty and confirm the results of other reports [16,24,27,35,40,56,58] that kyphoplasty may accelerate the restoration of patient functional mobility. The improvement in hospital discharge parameters may offset the initially higher cost of treatment and lead to a reduction in the use of medical resources after hospital discharge.…”

“…The authors concluded kyphoplasty is more effective than medical management of VCF. Despite these recent reports questioning the benefit of vertebral augmentation, the best evidence to date appears to support the use of kyphoplasty for treatment of symptomatic VCF [16,24,27,35,40,56,58]. No large-scale, nationwide studies have been performed to confirm the effect.…”

“…Percutaneous augmentation of vertebral fractures by vertebroplasty [2,14,42] or kyphoplasty [25,35,37,40] has been used as a minimally invasive method of stabilizing such fractures and thereby reducing the associated pain of fracture motion in patients who have failed nonoperative care, including spinal bracing, activity modification, or narcotic analgesic medications. Many reports to date suggest that at both short-and long-term followup, well-selected patients can expect pain relief that limits narcotic requirements and enhances function in up to 90% of cases treated with kyphoplasty [16,24,27,35,40,56,58]. Recent randomized, controlled studies have suggested vertebral augmentation procedures are no more efficacious than sham placebo procedures [4,34].…”

Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

“…Included Articles N=27 of the studies reported effects for the same group of patients and were combined into one analyzable ''study'' (Kasperk/Grafe et al, 4 total [11,12,24,25] and Rousing et al, 2 total [20,26]; see Table 1). This systematic review was reported in accordance with the PRISMA statement [27].…”

“…There is class I evidence to support the superiority of vertebral augmentation procedures (VAPs) over NSM [8][9][10], as well as non-randomized prospective studies [11][12][13], systematic reviews [14][15][16][17][18][19], and numerous retrospective series supporting safety and effectiveness of these procedures. However, recently published randomized controlled trials (RCTs) that showed no superiority of VP over NSM [20] or over a simulated procedure (sham) [21,22] have raised questions regarding the value of VP.…”