Department of Orthopaedic Surgery, Zucker School of Medicine at Hofstra/Northwell, 270-05 76th Avenue, New Hyde Park, NY 11040, USA.
Department of Orthopaedic Surgery, Zucker School of Medicine at Hofstra/Northwell, 270-05 76th Avenue, New Hyde Park, NY 11040, USA.
Spine J. 2021 Jul;21(7):1110-1117. doi: 10.1016/j.spinee.2021.02.020. Epub 2021 Feb 26.
The reoperation rate following TDR (Total Disc replacement) has been established at short- and mid-term time points through the Food and Drug Administration Investigational Device Exemption (FDA IDE) trials. However, these trials include highly selected centers and surgeons with strict governance of indications. The utilization of TDR throughout the community needs further analysis.
To identify the risk factors for lumbar spine reoperation in patients undergoing lumbar total disc replacement (TDR) at short-, mid-, and long-term follow-up.
STUDY DESIGN/SETTING: This study is a multi-center retrospective cohort study utilizing the New York Statewide Planning and Research Cooperative System database.
We identified 1,368 patients who underwent an elective primary lumbar TDR in New York State between January 1, 2005 and September 30, 2013.
The primary functional outcome of interest was lumbar reoperation, specifically the evaluation of independent risk factors for lumbar reoperation at a minimum of 2 years, with sub-analyses performed at 5 and ten years.
International Classification of Diseases, Ninth revision codes were utilized to identify patients undergoing a primary lumbar TDR. We excluded patients with primary/revision lumbar fusion procedures and revision disc replacement procedures. Hospital academic status was determined by the Accreditation Council for Graduate Medical Education. Unique encrypted patient identifiers allowed for longitudinal follow-up for reoperation. Logistic regression models compared reoperation and no-reoperation cohorts, and were performed on sub-analyses for significant univariate predictors of reoperation.
Between January 2005 and September 2013, 1368 patients underwent a primary lumbar TDR. Reoperation occurred in 8.8% by 2 years, 15.8% by 5 years, and 19.5% by ten years. Diabetics were more likely to have reoperations (7.5% vs 3.8%, p=.013). Teaching hospitals experienced a decreased reoperation rate compared to nonteaching hospitals at 2-year (5.0% vs 10.5%, p=.002), 5-year (10.7% vs 17.9%, p=.002) and 10-year (11.7% vs 21.9%, p=.045) follow-up. Lumbar fusion was the most common reoperation (14.2%).
We identified an 8.8% reoperation rate after inpatient lumbar TDR at 2-years, 15.8% at 5-years, and 19.5% at 10-years. When stratifying by teaching status, reoperation rates at teaching centers align with those reported in FDA IDE studies. Diabetes was the only patient factor influencing reoperation rate. There is a growing consensus that lumbar TDR is a durable and appropriate surgical option for lumbar degenerative disc disease. Proper indications are crucial to obtaining good outcomes with lumbar TDR.
通过食品和药物管理局（FDA）调查性器械豁免（IDE）试验，已经确定了 TDR（全椎间盘置换）后的再手术率在短期和中期时间点。然而，这些试验包括高度选择的中心和具有严格适应证管理的外科医生。全椎间盘置换术在整个社区的应用需要进一步分析。
确定在接受腰椎全椎间盘置换术（TDR）的患者中，在短期、中期和长期随访中腰椎再手术的风险因素。
研究设计/地点：本研究是一项多中心回顾性队列研究，利用纽约州全州规划和研究合作系统数据库。
我们确定了 1368 名在 2005 年 1 月 1 日至 2013 年 9 月 30 日期间在纽约州接受择期初次腰椎 TDR 的患者。
主要功能结局是腰椎再手术，特别是在至少 2 年的时间内评估腰椎再手术的独立风险因素，并在 5 年和 10 年进行亚分析。
利用国际疾病分类第九版代码识别接受初次腰椎 TDR 的患者。我们排除了接受初次/翻修腰椎融合术和翻修椎间盘置换术的患者。医院学术地位由研究生医学教育认证委员会确定。唯一的加密患者标识符允许对再手术进行纵向随访。逻辑回归模型比较了再手术和非再手术队列，并对再手术的显著单变量预测因素进行了亚分析。
在 2005 年 1 月至 2013 年 9 月期间，1368 名患者接受了初次腰椎 TDR。2 年时再手术率为 8.8%，5 年时为 15.8%，10 年时为 19.5%。糖尿病患者再手术的可能性更高（7.5%比 3.8%，p=.013）。与非教学医院相比，教学医院在 2 年（5.0%比 10.5%，p=.002）、5 年（10.7%比 17.9%，p=.002）和 10 年（11.7%比 21.9%，p=.045）随访时的再手术率较低。腰椎融合术是最常见的再手术（14.2%）。
我们发现，接受住院腰椎 TDR 治疗的患者在 2 年内的再手术率为 8.8%，5 年内为 15.8%，10 年内为 19.5%。当按教学状态分层时，教学中心的再手术率与 FDA IDE 研究报告的结果一致。糖尿病是唯一影响再手术率的患者因素。越来越多的人认为，腰椎 TDR 是治疗腰椎退行性椎间盘疾病的一种持久且合适的手术选择。获得腰椎 TDR 良好效果的关键是正确的适应证。
