Balloon kyphoplasty in the treatment of metastatic disease of the spine: a 2-year prospective evaluation

There is currently little data on the longer term efficacy and safety of balloon kyphoplasty (BKP) in patients with metastatic vertebral compression fractures (VCFs). To prospectively assess the long-term efficacy and safety of BKP in treating thoracic and lumbar spinal metastatic fractures that result in pain or instability. Sixty-five patients (37 men, mean age: 66 years) underwent 99 BKP procedures. Patient-related outcomes of pain visual analogue scale (VAS) and Oswestry Disability Index were assessed pre- and post-operatively and after 3, 6, 12 and 24 months. Correction of vertebral height and kyphotic deformity were assessed by radiographic measurements. Mean pain VAS and Oswestry Disability Index significantly improved from pre- to post-treatment (P < 0.0001), this improvement being sustained up to 24-month follow up. A gain in height restoration and a reduction of the post-operative kyphotic angle were seen post-operatively and at 3 months although these radiographic outcomes returned to pre-operative levels at 12 months. BKP was associated with a rate of cement leakage and incidence vertebral fracture of 12 and 8%, respectively. No symptomatic cement leaks or serious adverse events were seen during the 24 months of follow up. BKP is a minimally invasive procedure that provides immediate and long-term pain relief and improvement in functional ability in selected patients with metastatic VCFs. The procedure appears to have good long-term safety

A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

<p>Abstract</p> <p>Background</p> <p>The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.</p> <p>Methods</p> <p>The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.</p> <p>Discussion</p> <p>The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.</p> <p>Trial registration</p> <p>This study is registered at ClinicalTrials.gov., <a href="http://www.clinicaltrials.gov/ct2/show/NCT01200277">NCT01200277</a>.</p

Vertebroplasty and kyphoplasty: a comparative review of efficacy and adverse events

Vertebroplasty and kyphoplasty have become common surgical techniques for the treatment of vertebral compression fractures. Vertebroplasty involves the percutaneous injection of bone cement into the cancellous bone of a vertebral body with the goals of pain alleviation and preventing further loss of vertebral body height. Kyphoplasty utilizes an inflatable balloon to create a cavity for the cement with the additional potential goals of restoring height and reducing kyphosis. Vertebroplasty and kyphoplasty are effective treatment options for the reduction of pain associated with vertebral body compression fractures. Biomechanical studies demonstrate that kyphoplasty is initially superior for increasing vertebral body height and reducing kyphosis, but these gains are lost with repetitive loading. Complications secondary to extravasation of cement include compression of neural elements and venous embolism. These complications are rare but more common with vertebroplasty. Vertebroplasty and kyphoplasty are both safe and effective procedures for the treatment of vertebral body compression fractures

Differences in cyclic fatigue resistance between ProTaper next and ProTaper universal instruments at different levels

Introduction: New designs and alloys have been developed toincrease cyclic fatigue (CF) resistance of rotary files. the aim of this study was to compare CF resistance of ProTaper Universal (PTU) ; Dentsply Tulsa Dental, Tulsa, OK) and ProTaper Next (PTN, Dentsply Tulsa Dental) instruments at different points of curvature. Methods: A total of 420 files (240 PTU, S1, F1, f2 and F3 and 180 PTN, X1, X2 and X3) were divided in 14 groups of 30 instruments each. Instruments in groups s1-5, F1-5, X1-5, F2-5, x2-5, F3-5, and X3-5 were tested at 5 mm from the tip. groups F2-8, X2-8, F3-8 and X3-8 were tested at 8 mm (F2/X2 and F3/X3, respectively, had the same diameter at 8 mm). All files were rotated at 300 rpm until fracture. CF resistance was tested in stainless steel curved canals (60º, r=3 mm). Time to fracture was recorded. The mean half-life and beta and eta were calculated for each group and were compared with Weibull analysis. Results: PTN instruments will last significantly longer than PTU files with a probability higher than 98% at all tested levels except for S1, which was the significantly more resistant instrument to CF at 5 mm from the tip. Conclusions: PTU S1 was significantly the most resistant instrument at 5 mm from the tip. PTN files were significantly more resistant to CF than PTU instruments at all the other tested levels

Evidence for Reduced Fatigue Resistance of Contemporary Rotary Instruments Exposed to Body Temperature

IntroductionThe purpose of this study was to evaluate the effect of 2 different temperatures (20°C and 37°C) on the cyclic fatigue life of rotary instruments and correlate the results with martensitic transformation temperatures.MethodsContemporary nickel-titanium rotary instruments (n = 20 each and tip size #25, including Hyflex CM [Coltene, Cuyahoga Falls, OH], TRUShape [Dentsply Tulsa Dental Specialties, Tulsa, OK], Vortex Blue [Dentsply Tulsa Dental Specialties], and ProTaper Universal [Dentsply Tulsa Dental Specialties]) were tested for cyclic fatigue at room temperature (20°C ± 1°C) and at body temperature (37°C ± 1°C). Instruments were rotated until fracture occurred in a simulated canal with an angle curvature of about 60° and a radius curvature of 3 mm; the center of the curvature was 4.5 mm from the instrument tip. The number of cycles to fracture was measured. Phase transformation temperatures for 2 instruments of each brand were analyzed by differential scanning calorimetry. Data were analyzed using the t test and 1-way analysis of variance with the significance level set at 0.05.ResultsFor the tested size and at 20°C, Hyflex CM showed the highest resistance to fracture; no significant difference was found between TRUShape and Vortex Blue, whereas ProTaper Universal showed the lowest resistance to fracture. At 37°C, resistance to fatigue fracture was significantly reduced, up to 85%, for the tested instruments (P &lt; .001); at that temperature, Hyflex CM and Vortex Blue had similar and higher fatigue resistance compared with TRUShape and ProTaper Universal.ConclusionsUnder the conditions of this study, using a novel testing design, immersion in water at simulated body temperature was associated with a marked decrease in the fatigue life of all rotary instruments tested