Pettine Kenneth, Ryu Robert, Techy Fernando
*Rocky Mountain Associates in Orthopedic Medicine †Orthopedic Stem Cell Institute, Johnstown, CO ‡Department of Orthopaedics, The Ohio State University, Columbus, OH.
Clin Spine Surg. 2017 Jul;30(6):E743-E747. doi: 10.1097/BSD.0000000000000310.
A retrospective review of prospectively collected data.
To determine why artificial disk replacements (ADRs) fail by examining results of 91 patients in FDA studies performed at a single investigational device exemption (IDE) site with minimum 2-year follow-up.
Patients following lumbar ADR generally achieve their 24-month follow-up results at 3 months postoperatively.
Every patient undergoing ADR at 1 IDE site by 2 surgeons was evaluated for clinical success. Failure was defined as <50% improvement in ODI and VAS or any additional surgery at index or adjacent spine motion segment. Three ADRs were evaluated: Maverick, 25 patients; Charité, 31 patients; and Kineflex, 35 patients. All procedures were 1-level operations performed at L4-L5 or L5-S1. Demographics and inclusion/exclusion criteria were similar and will be discussed.
Overall clinical failure occurred in 26% (24 of 91 patients) at 2-year follow-up. Clinical failure occurred in: 28% (Maverick) (7 of 25 patients), 39% (Charité) (12 of 31 patients), and 14% (Kineflex) (5 of 35 patients). Causes of failure included facet pathology, 50% of failure patients (12 of 24). Implant complications occurred in 5% of total patients and 21% of failure patients (5 of 24). Only 5 patients went from a success to failure after 3 months. Only 1 patient went from a failure to success after a facet rhizotomy 1 year after ADR.
Seventy-four percent of patients after ADR met strict clinical success after 2-year follow-up. The clinical success versus failure rate did not change from their 3-month follow-up in 85 of the 91 patients (93%). Overall clinical success may be improved most by patient selection and implant type.
对前瞻性收集的数据进行回顾性分析。
通过研究美国食品药品监督管理局（FDA）在单一研究器械豁免（IDE）中心开展的、至少随访2年的91例患者的研究结果，确定人工椎间盘置换术（ADR）失败的原因。
接受腰椎ADR的患者通常在术后3个月时获得24个月的随访结果。
由2名外科医生在1个IDE中心为每位接受ADR的患者评估临床疗效。失败定义为：腰椎功能障碍指数（ODI）和视觉模拟评分（VAS）改善不足50%，或在索引节段或相邻脊柱运动节段进行任何额外手术。评估了3种ADR：Maverick（25例患者）、Charité（31例患者）和Kineflex（35例患者）。所有手术均为在L4-L5或L5-S1节段进行的单节段手术。人口统计学资料和纳入/排除标准相似，将予以讨论。
在2年随访时，总体临床失败率为26%（91例患者中的24例）。临床失败情况如下：Maverick为28%（25例患者中的7例），Charité为39%（31例患者中的12例），Kineflex为14%（35例患者中的5例）。失败原因包括小关节病变，占失败患者的50%（24例中的12例）。植入物并发症在全部患者中的发生率为5%，在失败患者中的发生率为21%（24例中的5例）。只有5例患者在3个月后从成功转变为失败。只有1例患者在ADR术后1年进行小关节神经根切断术后从失败转变为成功。
ADR术后2年随访时，74%的患者达到严格的临床成功标准。91例患者中的85例（93%）在3个月随访至2年随访期间，临床成功率与失败率未发生变化。通过患者选择和植入物类型，总体临床成功率可能得到最大程度的提高。
