The largest prospective controlled study performed so far comparing minimally invasive surgery in VCFs and non-surgical management was the Fracture Reduction Evaluation Study, a multi-center randomized control
trial in 300 patients with 5–6 weeks old VCFs comparing balloon kyphoplasty with non-surgical management [182]. In this trial, the primary outcome was the difference in change from baseline to 1 month in the SF-36 physical component summary in kyphoplasty-treated and control groups. At 1 month, patients quality of life was significantly improved after balloon kyphoplasty compared with non-surgical management (p < 0.0001) and this difference was maintained up to 1 year. Back pain score (VAS score) decreased more after kyphoplasty at 1 week (p < 0.0001) and after 12 months (p < 0.0034) compared with control; this improved pain was concomitant with significantly fewer
kyphoplasty patients #Selumetinib randurls[1|1|,|CHEM1|]# requiring opioid medications in the first 6 months. Cases of cement extravasation were asymptomatic. At 12 months, no between-group CP673451 concentration differences were observed in the proportion of patients with new or worsening radiographic vertebral fractures. Literature reviews report a cement leakage rate of about 10% with balloon kyphoplasty [183, 184]. Recent cost-effectiveness analyses using quality-adjusted life years suggest that balloon kyphoplasty may be a cost-effective treatment in osteoporotic patients hospitalized with painful
VCFs [185, 186]. In a number of prospective non-randomized studies and one prospective randomized trial comparing VP with BKP for treatment of osteoporotic VCFs [187–189], no significant differences could be documented for pain relief Bumetanide up to 6 months. However, a blinded, randomized clinical trial comparing vertebroplasty, balloon kyphoplasty and a sham procedure is lacking to state definitely of the advantage of one or the other procedure over conservative management. To conclusively determine whether rates of subsequent VCFs are higher among subjects undergoing balloon kyphoplasty compared with those treated non-surgically or with vertebroplasty would require a concurrently controlled study in which risk factors for fracture are evenly distributed across treatment groups. Conclusions It is likely that the optimal health of the skeleton requires an adequate equilibrium between all nutriments. Interactions between various nutriments, e.g. calcium and protein, and between some nutriments and exercise or other lifestyle habits much complicate the interpretation of studies aiming at defining the importance of a particular nutriment. Numerous studies have shown the beneficial effects of various types of exercise on bone mass but data with fracture as an endpoint are scanty.