ROI-C与传统融合器联合钛板内固定治疗颈椎病:颈椎稳定性重建及椎间融合的比较

ROI-C versus traditional fusion cage combined with titanium plate in treatment of cervical spondylosis: cervical stability reconstruction and intervertebral fusion

背景:颈椎前路减压融合内固定是治疗颈椎退行性疾病的经典术式,效果确切,但仍存在较多问题,以“零切迹”理念设计的ROI-C近年来临床运用也比较广泛,但其与传统术式治疗效果的比较研究较少。目的:比较分析ROI-C与传统融合器联合钛板在颈椎病前路椎间融合术中的临床疗效。方法:2012年4月至2015年12月对47例颈椎病患者开展颈椎前路减压融合内固定手术,随机分为2组,钛板组18例患者采用传统融合器联合钛板治疗,ROI-C组29例患者采用ROI-C融合器治疗。所有患者对治疗方案均知情同意,且得到医院伦理委员会批准。记录术中出血量、C臂机透视次数、手术时间、术后并发症及椎间融合情况;分别在术前及术后评估患者的疼痛目测类比评分及日本骨科协会脊髓功能评分。结果与结论:①术后患者均得到了门诊定期随访,时间为12-16个月,所有患者临床症状、脊髓功能明显改善,2组患者均未出现内植物松动移位及二次手术;②术后末次随访手术节段均获得融合,2组差异无显著性意义(P>0.05);③但ROI-C组患者的手术时间、术中出血量及术中C臂机透视次数均优于钛板组(P<0.05);④术后2组患者的日本骨科协会评分、目测类比评分均优于术前,但术后各时间点2组间差异无显著性意义(P>0.05);⑤提示ROI-C与传统融合器联合钛板在颈椎前路手术中均能获得较好的临床疗效,在有效恢复椎间隙高度、获得颈椎稳定性重建及椎体间融合方面无明显差异;但ROI-C组在手术时间、术中出血量以及避免因钢板置入引起的并发症方面存在明显优势,有望取代融合器联合钛板的传统手术方式。

BACKGROUND: Anterior cervical discectomy and fusion is classical and satisfactory for the treatment of cervical spondylosis, but there are still many problems. ROI-C designed with the concept of “zero-notch” has been widely used in clinical practice in recent years, but there are few comparative studies between ROI-C and traditional surgical treatment. OBJECTIVE: To compare and analyze the clinical effect of ROI-C and traditional fusion cage combined with titanium plate in the operation of cervical spondylosis. METHODS: From April 2012 to December 2015, 47 cases underwent anterior cervical decompression spondylotic myelopathy fusion and internal fixation surgery. They were divided into two groups. Patients in the titanium plate group (n=18) were treated by traditional fusion combined therapy with titanium plate. Patients in the ROI-C group (n=29) were treated by ROI-C fusion treatment. Informed consent was obtained from all patients. This study was approved by the Hospital Ethics Committee. Intraoperative blood loss, the number of C-arm fluoroscopy, operation time, postoperative complications and intervertebral fusion were recorded. Visual Analogue Scale score and Japanese Orthopaedic Association score were evaluated before and after operation. RESULTS AND CONCLUSION:(1) All patients were followed up regularly for 12-16 months. Clinical symptoms and spinal cord function of all patients were remarkably improved. Neither of the two groups had implant loosening or displacement or secondary surgery.(2) At the last follow-up, the operative segments were fused, but there was no significant difference between the two groups (P > 0.05).(3) Operation time, intraoperative blood loss and the number of C-arm fluoroscopy during operation were better in the ROI-C group than in the titanium plate group (P < 0.05).(4) Visual Analogue Scale score and Japanese Orthopaedic Association score were better after operation than those before operation in both groups, but no significant difference was found between the two groups at various time points (P > 0.05).(5) ROI-C and the traditional fusion cage with titanium plate can obtain good clinical curative effect in anterior cervical spine surgery. There was no significant difference in effective recovery of intervertebral space height, cervical stability reconstruction and interbody fusion. Nevertheless, ROI-C group has obvious advantages in operation time, intraoperative blood loss and avoidance of complications caused by plate implantation. It is hopeful that ROI-C will replace the traditional fusion cage combined with titanium plate.