Donk Roland D, Verbeek André L M, Verhagen Wim I M, Groenewoud Hans, Hosman Allard J F, Bartels Ronald H M A
Via Sana Clinics, Department of Orthopedic Surgery, Mill, the Netherlands.
Radboud university medical center, Department for Health Evidence, Nijmegen, the Netherlands.
PLoS One. 2017 Aug 29;12(8):e0183603. doi: 10.1371/journal.pone.0183603. eCollection 2017.
To investigate the efficacy of adding supplemental fusion or arthroplasty after cervical anterior discectomy for symptomatic mono-level cervical degenerative disease (radiculopathy), which has not been substantiated in controlled trials until now.
A randomized controlled trial is reported with 9 years follow up comparing anterior cervical anterior discectomy without fusion, with fusion by cage standalone, or with disc prosthesis. Patients suffering from symptomatic cervical disk degeneration at one level referred to spinal sections of department of neurosurgery or orthopedic surgery of a large general hospital with educational facilities were eligible. Neck Disability Index (NDI), McGill Pain Questionnaire Dutch language version (MPQ-DLV), physical-component summary (PCS), and mental-component summary (MCS) of the 36-item Short-Form Health Survey (SF-36), and re operation rate were evaluated.
142 patients between 18 and 55 years were allocated. The median follow-up was 8.9±1.9 years (5.6 to 12.2 years). The response rate at last follow-up was 98.5%. NDI at the last follow-up did not differ between the three treatment groups, nor did the secondary outcomes as MPQ-DLV and PCS or MCS from SF-36. The major improvement occurred within the first 6 weeks after surgery. Afterward, it remained stable. Eleven patients underwent surgery for recurrent symptoms and signs due to nerve root compression at the index or adjacent level.
This randomized trial could not detect a difference between three surgical modalities for treating a single-level degenerative disk disease. Anterior cervical discectomy without implant seems to be similar to anterior cervical discectomy with fusion by cage stand-alone or with disk prosthesis. Due to the small study sample size, this statement should be considered as inconclusive so far.
ISRCTN41681847.
探讨在症状性单节段颈椎退行性疾病（神经根病）行颈椎前路椎间盘切除术后加用补充融合术或关节成形术的疗效，此前该疗效在对照试验中尚未得到证实。
报告一项随机对照试验，随访9年，比较单纯颈椎前路椎间盘切除术、单独使用椎间融合器融合术或椎间盘假体植入术。在一家设有教学设施的大型综合医院的神经外科或骨科脊柱科室就诊的单节段症状性颈椎间盘退变患者符合入选标准。评估颈部残疾指数（NDI）、麦吉尔疼痛问卷荷兰语版（MPQ-DLV）、36项简短健康调查问卷（SF-36）的身体成分总结（PCS）和精神成分总结（MCS）以及再次手术率。
共纳入142例年龄在18至55岁之间的患者。中位随访时间为8.9±1.9年（5.6至12.2年）。末次随访时的应答率为98.5%。三个治疗组在末次随访时的NDI无差异，SF-36的MPQ-DLV、PCS或MCS等次要结局指标也无差异。主要改善发生在术后的前6周内。此后，情况保持稳定。11例患者因索引节段或相邻节段神经根受压导致的复发症状和体征接受了手术。
这项随机试验未能发现三种手术方式在治疗单节段退行性椎间盘疾病方面存在差异。单纯颈椎前路椎间盘切除术似乎与单独使用椎间融合器融合术或椎间盘假体植入术的颈椎前路椎间盘切除术相似。由于研究样本量较小，目前该结论应视为不确定。
ISRCTN41681847。
