Department of Neurosurgery, Medical Center Haaglanden, PO Box 432, 2501, CK The Hague, The Netherlands.
BMC Musculoskelet Disord. 2013 Aug 16;14:244. doi: 10.1186/1471-2474-14-244.
Anterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation. However, PEEK or metal cages have some undesirable imaging characteristics, leading to a search for alternative materials not creating artifacts on images; silicon nitride ceramic. Whether patients treated with silicon nitride ceramic cages have similar functional outcome as patients treated with PEEK cages is not known. We present the design of the CASCADE trial on effectiveness of ceramic cages versus PEEK cages in patients with cervical disc herniation and/or osteophytes.
METHODS/DESIGN: Patients (age 18-75 years) with monoradicular symptoms in one or both arms lasting more than 8 weeks, due to disc herniation and/or osteophytes, are eligible for the trial. The study is designed as a randomized controlled equivalence trial in which patients are blinded to the type of cage for 1 year. The total follow-up period is 2 years. The primary outcome measure is improvement in the Neck and Disability Index (NDI). Secondary outcomes measures include improvement in arm pain and neck pain (VAS), SF-36 and patients' perceived recovery. The final elements of comparison are perioperative statistics including operating time, blood loss, length of hospital stay, and adverse events. Lateral plane films at each follow-up visit and CT scan (at 6 months) will be used to judge fusion and the incidence of subsidence. Based on a power of 90% and assuming 8% loss to follow-up, 100 patients will be randomized into the 2 groups. The first analysis will be conducted when all patients have 1 year of follow-up, and the groups will be followed for 1 additional year to judge stability of outcomes.
While the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.
颈椎前路椎间盘切除融合术（ACDF）联合椎间融合器被认为是治疗颈椎间盘突出症的标准手术方法。然而，PEEK 或金属融合器存在一些不理想的影像学特征，因此需要寻找替代材料，避免在影像学上产生伪影，如氮化硅陶瓷。目前尚不清楚使用氮化硅陶瓷融合器治疗的患者与使用 PEEK 融合器治疗的患者在功能结果上是否相似。我们介绍了一项关于颈椎间盘突出症和/或骨赘患者使用陶瓷融合器与 PEEK 融合器的疗效的 CASCADE 试验的设计。
方法/设计：符合以下条件的患者可入选本研究：年龄 18-75 岁，单根神经根症状持续 8 周以上，由椎间盘突出和/或骨赘引起，且仅累及单侧或双侧上肢；研究采用随机对照等效试验设计，患者在 1 年内对融合器的类型保持盲法；总随访期为 2 年。主要结局指标为颈椎残障指数（NDI）的改善。次要结局指标包括手臂疼痛和颈部疼痛（VAS）、SF-36 评分和患者自我感知的恢复情况。比较的最终内容包括围手术期统计数据，包括手术时间、失血量、住院时间和不良事件。每次随访时拍摄侧位平片，在 6 个月时行 CT 扫描，以判断融合情况和沉降的发生率。基于 90%的效力和 8%的随访丢失率，将 100 例患者随机分为两组。当所有患者完成 1 年随访时，将进行第一次分析，两组将再随访 1 年，以判断结果的稳定性。
虽然新型陶瓷融合器已根据标准符合性和动物研究获得 CE 标志，但与金标准产品进行随机对照比较研究将为临床医生提供更具结论性的信息。只有在完成随机对照有效性试验后，才能实施任何新设备。
