Scholz Matti, Schelfaut Sebastiaan, Pingel Andreas, Schleicher Philipp, Kandziora Frank
Acta Orthop Belg. 2014 Dec;80(4):558-66.
The purpose of this prospective mono-centric case series study is to investigate the mid-term (minimum follow-up 24 months) safety and efficacy using a new "zero-profile" stand-alone cage with integrated angle-stable fixation in single- and multilevel anterior cervical fusions. 53 consecutive patients with radiculopathy/myelopathy at one to three levels underwent an anterior cervical discectomy and fusion procedure using the "zero-profile" implant (97 levels operated). A CT-scan at 12-months was taken to assess fusion status, implant failure, subsidence and migration. The overall fusion rate was 97%. 3 out of 45 patients (6.6%) complained about mild dysphagia related symptoms at 24 months follow-up . There was no recorded incidence of hardware failure. The new cervical stand-alone anterior fusion device allows a safe anterior cervical decompression and stabilisation, a low rate of chronic dysphagia and achieves a high fusion rate. Prospective randomised trials are necessary to confirm these results.
本前瞻性单中心病例系列研究的目的是，在单节段和多节段颈椎前路融合术中，使用一种新型的带有集成角度稳定固定装置的“零轮廓”独立椎间融合器，研究其中期（最短随访24个月）安全性和有效性。53例连续的一至三节段神经根型/脊髓型颈椎病患者接受了使用“零轮廓”植入物的颈椎前路椎间盘切除融合术（共手术97节段）。在术后12个月进行CT扫描，以评估融合状态、植入物失败、下沉和移位情况。总体融合率为97%。在24个月随访时，45例患者中有3例（6.6%）主诉有轻度吞咽困难相关症状。未记录到内固定失败的发生率。新型颈椎独立前路融合装置可实现安全的颈椎前路减压和稳定，慢性吞咽困难发生率低，并能达到高融合率。需要进行前瞻性随机试验来证实这些结果。
