Department of Neurosurgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
University of Groningen, University Medical Center Groningen, Groningen Spine Center, Groningen, The Netherlands.
BMJ Open. 2017 Jan 5;7(1):e012829. doi: 10.1136/bmjopen-2016-012829.
Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF.
The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed.
Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study.
NTR5536, pre-results.
由于神经孔的椎间盘源性或退变性狭窄引起的颈椎神经根病可以通过前路椎间盘切除术融合（ACDF）或后路椎间孔切开术（FOR）进行手术治疗。大多数外科医生更喜欢 ACDF，尽管有迹象表明 FOR 与 ACDF 同样有效，并发症发生率更低，成本更低。在随机对照试验中，尚未对头对头比较这两种手术技术进行比较。Foraminotomy ACDF Cost-Effectiveness Trial（FACET）研究的研究目的是比较 FOR 与 ACDF 的临床结果、并发症发生率和成本效益。
FACET 研究是一项在荷兰 7 家医疗中心进行的前瞻性随机对照试验。随访期为 2 年。主要纳入标准是由于单个水平的孤立颈椎椎间孔狭窄引起的 C4、C5、C6 或 C7 神经根根性病变，由软椎间盘和/或骨赘成分引起，需要手术减压。需要 308 例患者的样本量来检验 FOR 与 ACDF 的临床非劣效性假设。主要结局是：“手术成功”，通过视觉模拟量表评估神经根病的测量减少，以及“患者成功”，通过改良 Odom 标准评估。次要结局是：工作能力指数（单一项目 WAI）、生活质量（EuroQol 5 维度 5 级调查，EQ-5D-5L）、颈部残疾指数（NDI）和并发症。经济评估将评估成本效益。此外，还将进行预算影响分析。
已获得格罗宁根大学医学中心机构伦理委员会的伦理批准。该研究的结果将通过国家和国际论文进行传播。将向参与者和相关患者支持团体通报研究结果。
NTR5536，预结果。
