Osteoporotic vertebral fracture treatment
However, some patients fail to benefit from these treatment modalities and disease-related morbidity and mortality persists. Conservatively treated OVCF’s are cured with partial relief of pain and quality of life within 2 to 12 weeks 3) 4)
Kyphoplasty was developed to restore vertebral height and improve sagittal alignment. Several studies have shown these theoretical improvements cannot be transferred universally to the clinical setting.
The treatment of osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly since 1990s.
The treatment of painful vertebral compression fractures has changed substantially since the introduction of vertebroplasty in the mid-1980s and balloon kyphoplasty in the late 1990s. Both procedures were widely accepted with the vertebral fractures treated reaching 150,000 per annum in 2009 prior to the publication of 2 randomized controlled trials comparing vertebroplasty with a sham treatment published in the New England Journal of Medicine in August 2009. Since then, there has been a flood of information on vertebral augmentation and balloon kyphoplasty. It is worth evaluating this information especially because it relates to current recommendations that are often followed blindly by medical and administrative groups unfamiliar with either the procedure or the high level of evidence surrounding vertebral augmentation 5).
In a multicenter study, Kallmes et al., randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients’ ratings of average painintensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.
All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], -1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, -0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (51% vs. 13%, P<0.001) [corrected]. There was one serious adverse event in each group.
Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group 6).
On the other hand a randomized controlled trial (Fracture Reduction Evaluation [FREE] trial) which took place at 21 sites in eight countries and included 149 patients assigned to balloon kyphoplasty showed that in patients with acute, painful, vertebral fractures, balloon kyphoplasty improved quality of life, function, mobility, and pain more rapidly than did nonsurgical management, with significant differences in improvement between the groups at 1 month 7).