International Journal of Spine Surgery最新文献

This article is a reprint of a previously published article. For citation purposes, please use the original publication details: SAS J 2007;1(1):12-19. https://doi.org/10.1016/SASJ-2006-0002-RR) BACKGROUND: 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.

Methods: The author performed a new analysis of the Visual Analog Scale pain scores and the Oswestry Disability Index scores from the Charité artificial disc IDE study and used a nonparametric statistical test, because observed data distributions were not normal. The analysis included all of the enrolled subjects in both the nonrandomized and randomized phases of the study.

Results: Subjects from both the treatment and control groups improved from the baseline situation (P< .001) at all follow-up times (6 weeks to 24 months). Additionally, these pain and disability levels with artificial disc replacement were superior (P< .05) to the fusion treatment at all follow-up times including 2 years.

Conclusions: 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.

The evolution of spinal arthroplasty, a significant journey that began in the 1960s and 1970s, has seen remarkable progress. Initially designed to preserve motion at spinal segments and avoid complications associated with fusion surgeries, early designs faced setbacks due to rudimentary concepts and limited materials. However, the 1980s marked a turning point with the development of modern total disc replacement concepts, utilizing advanced materials such as titanium and polyethylene to improve implant longevity and integration. The early 2000s saw crucial approvals by the U.S. Food and Drug Administration, leading to broader clinical adoption.By the 2010s, cervical disc arthroplasty (CDA) had been refined through innovations such as patient-specific implants and the integration of robotics and surgical navigation. Cervical disc arthroplasty and lumbar disc arthroplasty are effective alternatives to fusion, particularly in preserving motion and reducing adjacent segment disease. Ongoing research continues to focus on viscoelastic arthroplasty and the integration of biologics to enhance outcomes, providing reassurance about the continuous improvement in spinal arthroplasty and instilling optimism about its future.Selecting patients for arthroplasty is a critical process that requires careful consideration. Ideal candidates display symptoms unresponsive to conservative treatments, have adequate disc height, and possess good bone quality. As arthroplasty typically preserves motion, it is less suited for patients with severe joint diseases or significant spinal stiffness. This emphasis on patient selection underscores the need for thorough evaluation and the importance of considering individual patient factors.Despite its benefits, the adoption of disc arthroplasty faces barriers such as high costs, stringent inclusion criteria, and the need for specialized surgical training. Overcoming these barriers requires advocacy, improved training, and potentially revising inclusion criteria to ensure more patients can benefit from these advanced treatments. The future of spinal arthroplasty looks promising, with potential advancements in biokinetics, biomaterials, and the broader application of minimally invasive techniques. This ongoing evolution promises to improve clinical outcomes and significantly enhance patient quality of life, offering hope for a better future in spinal arthroplasty.