Department of Neurosurgery, Maastricht University Medical Center+, P. Debyelaan 25, Maastricht, 6229 HX, The Netherlands.
Department of Neurosurgery, Zuyderland Medical Center, Henri Dunantstraat 5, Heerlen, 6419 PC, The Netherlands.
Trials. 2022 Aug 26;23(1):715. doi: 10.1186/s13063-022-06574-5.
To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term.
In this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery.
High-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.
ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.
迄今为止，对于治疗颈椎退行性椎间盘疾病（CDDD），哪种前路手术技术更具成本效益，尚无共识。对于单节段或多节段有症状的 CDDD 患者，最常用的手术治疗方法是前路颈椎间盘切除融合术（ACDF）。然而，新出现的神经根病和/或颈椎病的症状通常会在相邻节段发展，也称为临床相邻节段病变（CASP）。运动学、手术融合、自然病史和疾病进展在 CASP 发展中的作用程度尚不清楚。前路颈椎间盘切除人工关节置换术（ACDA）是另一种治疗选择，它被认为通过保留手术节段的运动来降低 CASP 的发生率。尽管 ACDA 通常不被鼓励，因为植入物成本更高，而临床结果与 ACDF 相似，但预防 CASP 可能是 ACDA 从长期来看更具成本效益的技术的一个原因。
在这项随机对照试验中，患者将以 1:1 的比例随机分配接受 ACDF 或 ACDA。纳入患有单节段或多节段 CDDD 且有神经根病和/或颈椎病症状的成年患者。主要结局是从医疗保健和社会角度评估两种技术的成本效益和成本效用。次要目标是两种技术之间临床和影像学结果的差异，以及前路减压手术的定性过程。所有结局将在基线时以及术后 6 个月至 4 年时进行测量。
关于 ACDA 和 ACDF 的成本效益的高质量证据缺乏；迄今为止，从社会角度来看，还没有前瞻性试验。考虑到人口老龄化和医疗保健成本的上升，迫切需要一项针对这一问题的可靠的临床成本效益试验。
ClinicalTrials.gov NCT04623593. 于 2020 年 9 月 29 日注册。
