Kotsias Andreas, Mularski Sven, Kühn Björn, Hanna Michael, Suess Olaf
Department of Orthopaedics and Traumatology, Helios Klinikum Emil von Behring, Berlin, Germany.
Department of Neurosurgery, Charité University Hospital, Berlin, Germany.
Patient Saf Surg. 2017 Apr 28;11:13. doi: 10.1186/s13037-017-0127-z. eCollection 2017.
Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium.
This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages.
There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group ( = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls ( = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused.
ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials.
Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.
颈椎前路椎间盘切除融合术（ACDF）是一种成熟的外科治疗方法。可使用多种类型的椎间融合器，但越来越多的证据表明，聚醚醚酮（PEEK）融合器融合效果不佳，因此临床改善效果较差。本研究的目的是评估使用部分涂钛的空PEEK融合器进行单节段ACDF的疗效。
这项前瞻性多中心单臂临床研究收集了6个月、12个月和18个月的随访数据。将其与另一项类似试验中使用设计相同的空的、未涂层的PEEK融合器治疗的匹配患者进行比较。
50例患者中有49例（98%）达到了视觉模拟评分（VAS）疼痛改善3分以上的最小临床重要差异（MCID），或18个月时VAS≤1。然而，即使在术后18个月，50例PEEK+Ti患者中也只有40例（80%）实现了完全骨融合。PEEK+Ti组（n = 49）在6个月时似乎比匹配的对照组（n = 49）融合评分稍好，疼痛缓解明显更好，但这些差异在12个月或18个月时并未持续存在。实现完全骨融合的患者（无论使用哪种植入物）在6个月时疼痛改善情况以及在6个月和12个月时功能障碍改善情况均明显优于未融合的患者。
ACDF是治疗颈椎病性脊髓病和神经根病的有效方法。尽管本研究和其他研究表明钛融合效果更好，但PEEK融合器的部分涂层并不能充分提高融合率或带来其他持久的临床益处。应在前瞻性随机对照试验中测试完全涂钛的PEEK融合器。
前瞻性、多中心、单臂临床观察性研究，无个体试验注册号。根据“PIERCE - PEEK研究”进行研究设计和事后数据分析，ISRCTN42774128，于2009年4月14日追溯注册。
