Percutaneous vertebroplasty is not a risk factor for new osteoporotic compression fractures: results from VERTOS II

Background and purpose: Pv is increasingly used as treatment for osteoporotic vcfs. However, controversy exists as to whether pv increases the risk for new vcfs during follow-up. The purpose of our research was to assess the incidence of new vcfs in patients with acute vcfs randomized to pv and conservative therapy. Materials and methods: Vertos ii is a prospective multicenter randomized controlled trial comparing pv with conservative therapy in 202 patients. Incidence, distribution, and timing of new vcfs during follow-up were assessed from spine radiographs. In addition, further height loss during follow-up of treated vcfs was measured. Results: After a mean follow-up of 11.4 Months (Median, 12.0; Range, 1-24 months), 18 New vcfs occurred in 15 of 91 patients after pv and 30 new vcfs in 21 of 85 patients after conservative therapy. This difference was not significant (P = .44). There was no higher fracture risk for adjacent-versus-distant vertebrae. Mean time to new vcf was 16.2 Months after pv and 17.8 Months after conservative treatment (Logrank, p = .45). The baseline number of vcfs was the only risk factor for occurrence (Or, 1.43; 95% Ci, 1.05-1.95) And number (P = .01) Of new vcfs. After conservative therapy, further height loss of treated vertebrae occurred more frequently (35 Of 85 versus 11 of 91 patients, p < .001) And was more severe (P < .001) Than after pv. Conclusions: Incidence of new vcfs was not different after pv compared with conservative therapy after a mean of 11.4 Months' follow-up. The only risk factor for new vcfs was the number of vcfs at baseline. Pv contributed to preservation of stature by decreasing both the incidence and severity of further height loss in treated vertebrae

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV):Randomised sham controlled clinical trial

Objective To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body. Design Randomised, double blind, sham controlled clinical trial. Setting Four community hospitals in the Netherlands, 2011-15. Participants 180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). Interventions Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group. Main outcome measures Main outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up. Results The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. Conclusions Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures

Treatment of osteoporotic vertebral compression fractures

In Chapter I, an outline of this thesis is given. In Chapter 2 we prospectively determined the natural course of pain in patients with conservatively treated acute osteoporotic vertebral compression fractures (VCF). In addition, we assessed the type of conservative therapy that these patients received. The natural fracture healing, in terms of pain relief, of an acute, osteoporotic VCF mainly took place within the first 6 months. In view of the high percentage (31%) of patients with chronic pain due to an acute VCF with conservative therapy only, minimal invasive techniques should be considered. In the Netherlands, conservative treatment mainly consists of pain medication and physiotherapy and is prescribed by the general practitioner. In Chapter 3 rationale, objectives and design of the VERTOS II study are described. VERTOS II is an open-label randomized controlled trial comparing percutaneous vertebroplasty (PV) with optimal conservative pain management. In Chapter 4 the main outcomes of the VERTOS II study are analyzed en discussed. Our results show that in patients with acute osteoporotic VCFs who have persistent severe pain, PV done at a mean 5.6 weeks after onset of symptoms resulted in quicker and greater pain relief than conservative treatment did. Pain relief was sustained throughout a year of follow-up. After PV, patients used a lower class of drugs than did those receiving conservative treatment, or no drugs at all. With conservative treatment, pain relief was slower and less than with PV, and pain treatment required tended to increase during the first month. Some patients (24%) in the control group developed chronic back pain, possibly because of non-healing of the fracture. For both quality of life and function, improvement with time was significantly greater and quicker after PV than with conservative treatment. Incremental costs of PV roughly equaled procedural costs. The cost of one pain-free day gained was €20. The trial-based incremental cost-effectiveness ratio for PV, as compared with conservative treatment, was €22,685 per quality adjusted life year gained. The resulting incremental cost-effectiveness suggests that PV seemed warranted for the patients with VCFs treated at a mean 5.6 weeks after start of symptoms. In Chapter 5 we found that the incidence of new VCFs in patients with an acute osteoporotic VCF was not different after PV compared with conservative therapy in the first year of follow-up. The only risk factor for the occurrence of new VCFs was the number of VCFs at baseline indicating the severity of osteoporosis. PV contributed to preservation of stature by decreasing the incidence and severity of further height loss in treated vertebral bodies. In Chapter 6 we assessed the incidence of pulmonary cement embolism by performing native chest CT during follow-up in a large proportion of patients from the VERTOS II trial. Small and clinically silent pulmonary cement embolism occurred in a quarter of patients treated with PV. Cement leakage into the azygos vein was the only risk factor. With time, these small cement emboli remained inert on follow-up CT, without inflammatory pulmonary response. Standard post-procedural CT or chest radiographs are not necessary. In Chapter 7 we assessed the incidence, anatomical location, and clinical impact of perivertebral cement leakage on short- and long-term in a large patient cohort. Cement leakage after PV outside the vertebral body was frequently detected on CT. Most leakages are into adjacent disks or segmental veins and all patients were asymptomatic. Cement leakage occurred more frequently with higher injected volumes. Late cement migration during follow-up did not occur. Standard post-procedural CT of the treated vertebral body in PV is not necessary. In Chapter 8 pain management during PV is evaluated. In a substantial proportion of patients, local anaesthesia was not sufficient for pain reduction during PV. The severity of pain experienced by the patient is usually not appreciated correctly by the operator. In Chapter 9 the results of the VERTOS II study are interpreted and the clinical implications are discussed

Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

Background Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. Methods Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. Findings Between Oct 1,2005, and June 30,2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5.2 (95% CI -5.88 to -4.72) after vertebroplasty and -2.7 (-3.22 to -1.98) after conservative treatment, and between baseline and 1 year was -5.7 (-6.22 to -4.98) after vertebroplasty and -3-7 (-4.35 to -3.05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2.6 (95% CI 1.74-3.37, p<0.0001) at 1 month and 2.0 (1.13-2.80, p<0.0001) at 1 year. No serious complications or adverse events were reported. Interpretation In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost