BackgroundVertebral compression fractures (VCFs) can cause significant pain and functional impairment, and their cumulative effect can lead to progressive morbidity. This single-arm, prospective feasibility trial, conducted at 4 clinical sites, was undertaken to evaluate the clinical outcomes associated with the use of an innovative vertebral augmentation device, the Kiva VCF Treatment System (Benvenue Medical, Santa Clara, California), in the management of symptomatic VCFs associated with osteoporosis.MethodsVertebral augmentation treatment was performed for persistent back pain symptoms in 57 patients (mean age, 71.9 ± 10.4 years), including 46 women, with radiologically confirmed VCFs; 36 of these patients (63%) had reached 12 months of follow-up at this data analysis. There were 51 one-level cases, 5 two-level cases, and 1 three-level case, representing 64 treated levels. Back pain severity and condition-specific functional impairment were evaluated with a standard 100-mm visual analog scale and the Oswestry Disability Index (ODI), respectively, before device implantation as well as at 6 weeks, 3 months, and 12 months.ResultsMarked clinical improvements were realized in back pain severity and functional impairment through 12 months of follow-up. The mean back pain score on the visual analog scale improved from 79.3 ± 17.2 before treatment to 21.9 ± 21.3, 21.9 ± 24.6, and 23.2 ± 23.3 at 6 weeks, 3 months, and 12 months, respectively. The mean decrease at 12 months was 49.9 ± 30.3 mm, or approximately 66% (P < .0001). Similarly, the mean ODI score improved from 68.1% ± 16.9% before treatment to 27.4% ± 17.2%, 23.8% ± 18.7%, and 23.3% ± 15.5% at 6 weeks, 3 months, and 12 months, respectively, representing a mean change of 39.2 ± 19.6 percentage points, or approximately 63%, at 12 months. Overall clinical success rates based on a 30% improvement in pain severity or greater and maintenance or improvement in the ODI were 91%, 88%, and 89% at 6 weeks, 3 months, and 12 months, respectively. The vertebral augmentation procedure required injection of a mean of 2.2 ± 0.12 mL of cement per vertebral body. There were 5 levels (8%) where cement extravasation was identified radiographically, and none were related to clinical symptoms.ConclusionsThese pilot findings are encouraging, suggesting robust and durable clinical improvement after this novel vertebral augmentation procedure in patients with painful VCFs.
OBJECTIVE: to describe a new posterior minimally invasive method of facet stabilization for treatment of the degenerating lumbar motion segment. The biomechanics of this Percudyn (Interventional Spine; Irvine, CA) system are distinct from that of other interspinous dynamic stabilization systems as it acts bilaterally directly within the middle column of the spine. Based on biomechanical evalution, the paired prosthesis supports, cushions, and reinforces the facet complexes by limiting both extension and lateral bending thereby maintaining central and foraminal volumes. METHODS: the Percudyn device consists of a pedicle anchor upon which sits a cushioning polycarbonate-urethane stabilizer that serves as a mechanically reinforcing stop between the inferior and superior articular facets. A 1.5 cm skin incision is made bilaterally over the lower pedicle of the treated segment through which a Jamshidi needle is percutaneously targeted under biplanar fluoroscopic guidance into the caudal aspect of the superior articular process directly underneath the lip of the inferior facet from the level above. Progressive onestep tubular dilation is then performed to secure a small disposable working portal. Through this access, the Percudyn stabilizers are then placed over the wire and anchored bilaterally into the inferior pedicles of the degenerated motion segment. RESULTS: three patients (ages 26-41, male) with significant low back pain as well as radiculopathy with lateral recess stenosis from a large disc herniation/ ligamentum and facet hypertrophy (L4-5 and/or L5-S1) underwent a minimally invasive decompression/ discectomy and bilateral Percudyn placement at each disease level. Each patient had significant relief of both his radiculopathy and axial back pain post-operatively and was discharged home within 18 hours without sequelae. CONCLUSION: this novel technique of percutaneous posterior facet augmentation allows for safe placement of bilateral middle column prostheses that act as mechanical cushions between the articulating facets thereby limiting extension and lateral bending and also preventing compression of the neural elements. As the Percudyn device serves to reinforce the middle column directly at the level of the facet, it represents a new class of posterior motionpreserving stabilization which may serve to mitigate segmental axial back pain as has been described for other posterior dynamic stabilization systems.
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