SAS journal
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The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE) study led to a conclusion that clinical outcomes following lumbar arthroplasty were at least as good as outcomes from fusion. ⋯ The a priori statistical plan for an IDE study may not adequately address the final distribution of the data. Therefore, statistical analyses more appropriate to the distribution may be necessary to develop meaningful statistical conclusions from the study. A nonparametric statistical analysis of the Charité artificial disc IDE outcomes scores demonstrates superiority for lumbar arthroplasty versus fusion at all follow-up time points to 24 months.
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Although total disc replacement has been performed for years outside the United States, relatively little available data address clinical outcomes, particularly data from prospective studies. We report the 24- to 36-month follow-up of one center's experience with the ProDisc-L artificial disc as part of a prospective, randomized trial comparing total disc arthroplasty to combined anterior-posterior lumbar fusion. ⋯ We found that results of total disc replacement were at least as good as those achieved with combined instrumented anterior-posterior fusion for the treatment of painful disc degeneration. Favorable results were maintained during 24- and 36-month follow-up.
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We sought to construct a general methodology for objectively quantifying the learning curve associated with any surgical technique and to determine the number of cases needed to achieve a success rate of 90% for the technique of transforaminal endoscopic lumbar discectomy. To our knowledge, no other studies have observed the learning curve of endoscopic lumbar discectomy by transforaminal approach. ⋯ The method developed to establish the learning curve of a surgical procedure, based on outcome and surgical time, may be used to assess any new procedure. With respect to the transforaminal endoscopic technique, the determination of a specific number of cases (72) needed to master (achieve 90% excellent/ good results) could help orient surgeons willing to adopt this technique.
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Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. ⋯ The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study.
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Endoscopic spine surgery has evolved gradually through improvements in endoscope design, instrumentation, and surgical techniques. The ability to visualize and treat painful pathology endoscopically through the foramen has opened the door for the diagnosis and treatment of degenerative conditions of the lumbar spine (from T10 to S1). Other endoscopic techniques for treating a painful disc have been focused on a posterior approach and has been compared with micro-lumbar discectomy. These procedures have not been more effective than open microdiscectomy but are less invasive, have less surgical morbidity, and allow for more rapid surgical recovery. Spinal decompression and fusion was the fallback procedure when nonsurgical treatment or discectomy failed to relieve sciatica and back pain. Foraminal endoscopic surgery, however, provides a truly minimally invasive alternative approach to the pathoanatomy of the lumbar spine because it preserves the multifidus muscle, maintains motion, and eliminates or, at worst, delays the need for fusion. ⋯ New skills will become desirable and necessary for the spine surgeon to keep up with endoscopic technology in spine care. The emphasis is on visualization of painful pathoanatomy and preservation of mobility. A new focus is on nucleus replacement, annular repair, annular reinforcement, biologics, and even transforaminal interbody fusion as the procedure of last resort. The transforaminal surgical approach to the lumbar spine can allow for minimally invasive access without negatively affecting and destabilizing the multifidus muscle.