Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
Eur Spine J. 2011 Feb;20(2):177-84. doi: 10.1007/s00586-010-1583-7. Epub 2010 Oct 10.
Cervical total disc replacement (CTDR) has been increasingly used as an alternative to fusion surgery in patients with pain or neurological symptoms in the cervical spine who do not respond to non-surgical treatment. A systematic literature review has been conducted to evaluate whether CTDR is more efficacious and safer than fusion or non-surgical treatment. Published evidence up to date is summarised qualitatively according to the GRADE methodology. After 2 years of follow-up, studies demonstrated statistically significant non-inferiority of CTDR versus fusion with respect to the composite outcome 'overall success'. Single patient relevant endpoints such as pain, disability or quality of life improved in both groups with no superiority of CTDR. Both technologies showed similar complication rates. No evidence is available for the comparison between CTDR and non-surgical treatment. In the long run improvement of health outcomes seems to be similar in CTDR and fusion, however, the study quality is often severely limited. After both interventions, many patients still face problems. A difficulty per se is the correct diagnosis and indication for surgical interventions in the cervical spine. CTDR is no better than fusion in alleviating symptoms related to disc degeneration in the cervical spine. In the context of limited resources, a net cost comparison may be sensible. So far, CTDR is not recommended for routine use. As many trials are ongoing, re-evaluation at a later date will be required. Future research needs to address the relative effectiveness between CTDR and conservative treatment.
颈椎全椎间盘置换术(CTDR)已越来越多地被用作颈椎疼痛或神经症状患者的替代融合手术方法,这些患者对非手术治疗无反应。进行了系统的文献回顾,以评估 CTDR 是否比融合或非手术治疗更有效和更安全。根据 GRADE 方法,对截至目前的已发表证据进行了定性总结。在 2 年的随访后,研究表明 CTDR 在复合终点“总体成功率”方面与融合相比具有统计学上的非劣效性。两组患者的单患者相关终点(如疼痛、残疾或生活质量)均有所改善,且 CTDR 没有优势。两种技术的并发症发生率相似。尚无 CTDR 与非手术治疗比较的证据。从长远来看,CTDR 和融合在改善健康结果方面似乎相似,但研究质量往往受到严重限制。在两种干预措施之后,许多患者仍然面临问题。本身的一个困难是正确诊断和对颈椎手术干预的指征。在缓解与颈椎间盘退变相关的症状方面,CTDR 并不优于融合。在资源有限的情况下,进行净成本比较可能是合理的。到目前为止,CTDR 不建议常规使用。由于许多试验正在进行中,以后需要重新评估。未来的研究需要解决 CTDR 与保守治疗之间的相对有效性。