颈椎关节成形术的极晚期并发症：来自单一研究中心的 2 项对照随机前瞻性研究结果。
Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.
机构信息
From the Oregon Neurosurgery Specialists, Springfield, OR.
出版信息
Spine (Phila Pa 1976). 2013 Dec 15;38(26):2223-6. doi: 10.1097/BRS.0000000000000060.
STUDY DESIGN
Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices.
OBJECTIVE
To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices.
SUMMARY OF BACKGROUND DATA
Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less.
METHODS
Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction.
RESULTS
Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms.
CONCLUSION
Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery.
LEVEL OF EVIDENCE
研究设计
前瞻性、单中心、随机、美国食品和药物管理局批准的 2 种颈椎关节置换术（CA）设备的研究性设备豁免临床试验。
研究目的
评估在 Bryan 和 Prestige LP 关节置换术设备的美国食品和药物管理局临床试验中，手术后 4 年以上发生的 CA 并发症。
背景资料总结
几项随机临床研究报告显示，CA 是治疗退行性颈椎间盘疾病的一种安全有效的替代前路颈椎融合术的方法。大多数研究包括 4 年或更短的随访期。
方法
在 2002 年至 2006 年期间，94 名患者参加了 Bryan 和 Prestige LP 颈椎间盘设备的美国食品和药物管理局研究。对接受关节置换术且在手术后 4 年以上因颈部相关疼痛或功能障碍返回的患者进行了图表、影像学研究和医院记录的审查。
结果
排除融合和置换术患者相似的相邻节段疾病后，5 名患者因颈部和手臂症状在手术后 48 至 72 个月返回评估，所有患者均接受置换术治疗。4 名患者出现假体周围椎体骨丢失。1 名患者出现假体后迁移并出现脊髓病。3 名患者需要进行翻修手术，2 名患者进行了观察。4 名患者保持随访并报告症状稳定或改善。
结论
尽管存在相似之处，但在这项研究中，CA 和融合在晚期并发症方面并非等效手术。与大关节置换术类似，CA 可能会出现延迟的器械相关并发症。这些并发症发生在与更传统的颈椎手术相关并发症的时间框架之外。患者和外科医生都应该意识到 CA 可能发生非常晚期的器械相关并发症，以及需要进行翻修手术。
证据水平
1。
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