纳米羟基磷灰石／聚酰胺66融合器在颈椎前路椎间融合术中应用的中期效果

Clinical effect of the nano-hydroxyapatite/polyamide66 cage in reconstruction of cervical stability: a midterm follow-up study

中文关键词:  颈椎  脊柱融合术  纳米羟基磷灰石/聚酰胺66  聚醚醚酮

英文关键词:Cervical vertebrae  Spinal fusion  Nano-hydroxyapatite／polyamide 66  Polyetheretherketone

中文摘要:

  【摘要】 目的：探讨纳米羟基磷灰石/聚酰胺66椎间融合器（n-HA/PA66 cage）重建颈椎前中柱稳定性的中期效果。方法：回顾性分析2010年1月~2012年1月在我院行颈前路减压椎间盘切除植骨融合内固定术（anterior cervical discectomy and fusion，ACDF）的患者。根据术中所用的植骨材料不同将患者分为两组：A组采用n-HA/PA66 cage植骨融合，124例；B组采用PEEK cage植骨融合，50例。比较两组的性别、年龄、术中出血量、手术时间、并发症发生率、术后影像学和临床疗效。影像学评价包括颈椎曲度、融合节段曲度、融合节段高度，采用Brantigan评分判断植骨融合和cage下沉、移位等情况。临床疗效采用视觉模拟量表（visual analog scale，VAS）评分、日本骨科学会（Japanese Orthopaedic Association，JOA）评分和颈椎功能障碍指数（neck disability index，NDI）评价。结果：两组患者性别比、年龄、术前VAS评分、JOA评分、NDI，术前颈椎曲度、融合节段高度、融合节段曲度、手术时间、术中出血量等均无统计学差异（P>0．05）。术后B组2例患者出现短暂的咽喉部不适，术后72h消失，无吞咽困难发生。所有患者均未出现脑脊液漏、血肿、切口感染等并发症。所有患者术后均获得随访，A组随访52.10±24.30个月，B组随访49.50±26.50个月，两组随访时间无统计学差异（P>0．05）。末次随访时两组患者VAS评分、NDI及JOA评分较术前均有显著性改善（P<0．05）；术后和末次随访时融合节段高度、融合节段曲度、颈椎曲度与术前比较均有显著性差异（P<0．05），两组同时间点比较均无显著性差异（P>0．05）。A组2例患者cage出现下沉，B组3例患者cage出现下沉，两组下沉率比较有统计学差异(P<0．05)。其他患者未发现cage移位、破裂以及其他内固定并发症。两组患者末次随访时均获得满意融合（Brantigan评分均≥3分），融合时间分别为4.2±1.8个月及4.1±2.0个月（P>0．05）。结论：应用n-HA/PA66 cage行颈前路椎间植骨融合的骨融合率与PEEK cage相似，可维持融合节段高度及曲度，是一种较理想的颈椎前中柱重建材料。

英文摘要:

  【Abstract】 Objectives: To explore the midterm outcomes of nano-hydroxyapatite/polyamide66 cage(n-HA/PA66 cage) in reconstructing the stability of anterior and middle cervical column by comparing with polyetheretherketone PEEK cage． Methods: A total of 174 patients who underwent the anterior cervical discectomy and fusion(ACDF) between January 2010 and January 2012 was reviewed. They were divided into two groups according to the implanted cage: 124 cases with n-HA/PA66 cage in group A, and 50 cases with PEEK cage in group B. Sex, age, intraoperative blood loss, operation time, complication rate, postoperative image and clinical effect were compared between two groups. The following radiographic measurements in all the patients were observed: cervical spine alignment, fused segments height, fused segments alignment. The rate of cage subsidence, cage displacement and bone fusion were evaluated by Brantigan score. The clinical outcomes were evaluated by visual analogue scale(VAS) score, Japan Orthopaedic Association(JOA) score and neck disability index(NDI). Results: There were no significant differences(P>0.05) of sex, age, preoperative VAS, preoperative JOA, preoperative NDI, operation time, cervical spine alignment, fused segments height, fused segments alignment, hospitalization time and intraoperative blood loss between two groups. In group B, 2 patients showed temporary sore throat, which disappeared in 72 hours after operation without dysphagia. No cerebrospinal fluid leakage, hematoma or wound infection was found in all patents. Patients had been followed up for an average of 52.10±24.30 months in group A, and 49.50±26.50 months in group B, without significant difference between the two groups(P>0.05). Cage subsidence occurred in 2 cases of group A and 3 cases of group B, there was significant difference of subsidence rate between the two groups(P<0.05). The cervical spine alignment, fused segments height, fused segments alignment singnificantly improved at postoperative and final follow-up. But, there was no significant difference of cervical spine alignment, fused segments height, fused segments alignment at postoperative or final follow-up between two groups(P>0.05). There was no cage displacement, cage breakage or other implant complication in the other patients. The Brantigan score was more than or 3 points in all the patients which showed satisfied fusion rate. The fusion time was 4.2±1.8 months in group A, and 4.1±2.0 months in group B, and there was no significant difference between the two groups(P>0．05). Conclusions: The n-HA/PA66 cage has satisfied similar rate of osseous fusion as PEEK cage and can effectively restore and maintain the height and alignment of fused segments. The n-HA/PA66 cage is an ideal bioactive material in the reconstruction of anterior and middle cervical column.