Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands.
BMC Musculoskelet Disord. 2010 Jun 16;11:122. doi: 10.1186/1471-2474-11-122.
Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation.
METHODS/DESIGN: Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years.
Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prosthesis is necessary and cost-effective will be determined by this trial.
Netherlands Trial Register NTR1289.
对于经保守治疗无效的椎间盘突出症所致神经根型颈椎病患者，可采用手术治疗。前路颈椎间盘切除术是标准的手术方法，常与椎体间融合术联合使用。长期以来，加速的相邻椎间盘退变是已知的事实。最近，开发了颈椎间盘假体以保持运动并可能降低相邻椎间盘退变的发生率。尚未进行针对相邻节段退变和功能结果的比较成本效益研究。我们介绍了 NECK 试验的设计，这是一项针对颈椎间盘突出症患者前路颈椎间盘切除术联合或不联合椎体间融合及关节置换术的成本效益的随机研究。
方法/设计：纳入因单节段颈椎间盘突出症持续超过 8 周而出现神经根症状的患者（年龄 18-65 岁）。患者将被随机分为 3 组：单纯前路椎间盘切除术、前路椎间盘切除术联合椎体间融合术和前路椎间盘切除术联合椎间盘假体。主要结局测量指标为术后 2 年和 5 年时的症状性相邻椎间盘退变。其他结局参数包括颈椎残障指数、感知恢复、手臂和颈部疼痛、并发症、再手术、生活质量、工作满意度、焦虑和抑郁评估、医疗消费、缺勤和成本。该研究是一项随机前瞻性多中心试验，以平行组设计比较 3 种手术技术。患者和研究护士将在 2 年内对分配的治疗保持盲法。随访期为 5 年。
目前，前路颈椎间盘切除术联合融合术是颈椎间盘突出症手术治疗的金标准。是否需要额外的椎体间融合或椎间盘假体以及是否具有成本效益，将由本试验确定。
荷兰临床试验注册中心 NTR1289。
