SAS journal
-
The Kineflex lumbar artificial disc replacement device (SpinalMotion, Mountain View, California) is a semiconstrained, posterior center of rotation, metal-on-metal intervertebral disc prosthesis. We performed a prospective, randomized, non-inferiority trial comparing the Kineflex Disc with the Food and Drug Administration (FDA)-approved Charité device (DePuy Spine, Raynham, Massachusetts). Our objective was to evaluate the Kineflex Disc's safety and efficacy using validated outcomes measures-the visual analog scale (VAS) and the Oswestry Disability Index (ODI). ⋯ This level I evidence shows the Kineflex Disc to be non-inferior to the Charité device in terms of pain reduction (VAS score) and FDA-defined clinical success at 24 months' follow-up. Both devices showed a high degree of safety.
-
Vertebral 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. ⋯ These pilot findings are encouraging, suggesting robust and durable clinical improvement after this novel vertebral augmentation procedure in patients with painful VCFs.
-
The utility and cost of minimally invasive surgical (MIS) fusion remain controversial. The primary objective of this study was to compare the direct economic impact of 1- and 2-level fusion for grade I or II degenerative or isthmic spondylolisthesis via an MIS technique compared with conventional open posterior decompression and fusion. ⋯ Level III.
-
To evaluate outcomes after minimally invasive transforaminal lumbar interbody fusion (MI-TLIF). ⋯ For carefully selected patients, MI-TLIF has a very favorable long term outcome that is comparable to conventional open TLIF, with the added benefit of decreased adjacent tissue injury.
-
Although some investigators believe that the rate of postoperative instability is low after lumbar spinal stenosis surgery, the majority believe that postoperative instability usually develops. Decompression alone and decompression with fusion have been widely used for years in the surgical treatment of lumbar spinal stenosis. Nevertheless, in recent years several biomechanical studies have shown that posterior dynamic transpedicular stabilization provides stabilization that is like the rigid stabilization systems of the spine. Recently, posterior transpedicular dynamic stabilization has been more commonly used as an alternative treatment option (rather than rigid stabilization with fusion) for the treatment of degenerative spines with chronic instability and for the prevention of possible instability after decompression in lumbar spinal stenosis surgery. ⋯ Posterior dynamic stabilization without fusion applied to lumbar decompression leads to better clinical and radiologic results in degenerative lumbar spinal stenosis. To avoid postoperative instability, especially in elderly patients who undergo degenerative lumbar spinal stenosis surgery with chronic instability, the application of decompression with posterior dynamic transpedicular stabilization is likely an important alternative surgical option to fusion, because it does not have fusion-related side effects, is easier to perform than fusion, requires a shorter operation time, and has low morbidity and complication rates.