Skeppholm Martin, Lindgren Lars, Henriques Thomas, Vavruch Ludek, Löfgren Håkan, Olerud Claes
Stockholm Spine Center, Löwenströmska Hospital, SE-194 89, Upplands Väsby, Sweden; Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden.
Stockholm Spine Center, Löwenströmska Hospital, SE-194 89, Upplands Väsby, Sweden.
Spine J. 2015 Jun 1;15(6):1284-94. doi: 10.1016/j.spinee.2015.02.039. Epub 2015 Feb 28.
Several previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study.
To compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years.
STUDY DESIGN/SETTING: This is a randomized controlled multicenter trial, including three spine centers in Sweden.
The study included patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included.
Self-assessment with Neck Disability Index (NDI) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables.
Patients were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both patient and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up.
Data were available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with NDI values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two patients in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups.
Artificial disc replacement did not result in better outcome compared to fusion measured with NDI 2 years after surgery.
此前已有多项比较人工椎间盘置换术（ADR）和融合术的研究，结果谨慎地倾向于ADR。与大多数先前的研究不同，本研究并非美国食品药品监督管理局要求的用于产品上市批准的研究性器械豁免研究。本研究部分资金由销售本研究中使用的人工椎间盘的公司提供的无限制机构研究资助。
比较人工椎间盘与前路颈椎减压融合术（ACDF）治疗效果，并记录两种治疗在2年随访期内的相关并发症。
研究设计/地点：这是一项随机对照多中心试验，包括瑞典的三个脊柱中心。
该研究纳入了符合纳入标准的因颈椎神经根病寻求治疗的患者。总共纳入了153例患者。
以颈部残疾指数（NDI）作为主要观察变量进行自我评估，以EQ-5D和视觉模拟量表作为次要观察变量。
患者被随机分配接受Depuy Discover人工椎间盘治疗或髂嵴植骨融合钢板内固定治疗。随机分组对患者和护理人员均保密，直至植入手术时。记录不良事件、并发症、翻修手术以及失访情况。
137例（91%）纳入并最初接受治疗的患者有可用数据。两组术后均有显著改善。意向性分析中，NDI从63.1降至39.8。ADR组和ACDF组的NDI值分别为39.1和40.1，无统计学显著差异。在次要观察指标（EQ-5D和视觉模拟量表）方面，两组之间也未显示出任何统计学显著差异。ADR组有9例患者和融合组有3例患者因各种原因接受了二次手术。每组各有2例患者因相邻节段病变接受了二次手术。两组并发症发生率无统计学显著差异。
术后2年，与融合术相比，用NDI衡量，人工椎间盘置换术并未带来更好的治疗效果。
