Department of Orthopedics, West China Hospital, Sichuan University, 37# Guoxue Rd, Chengdu 610041, People's Republic of China.
Int Orthop. 2013 Jul;37(7):1315-25. doi: 10.1007/s00264-013-1883-8. Epub 2013 May 4.
To compare the efficacy and safety of TDR to that of the fusion for the treatment of lumbar degenerative disc disease (LDDD).
Randomized controlled trials comparing TDR with any other intervention for LDDD were acquired by a comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and the FDA trials register. Methodologic quality was assessed and relevant data were retrieved, and appropriate meta-analysis was performed. Two review authors independently selected studies, extracted data, and assessed risk of bias. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences.
Six relevant randomized controlled trials (RCTs) involving 1,603 patients were identified and reported two year follow-up results. Patients in TDR group compared with lumbar fusion group demonstrated significant improvements in ODI, VAS scores and complication rates at the two year follow-up. Meanwhile, except for operating time in anterior group, intra-operative blood loss, operating time in posterior group, and reoperation rate were without clinical significance between the two groups. In addition, the range of motion (ROM) was maintained within normal ranges after TDR.
The results showed the TDR has significant safety and efficacy comparable to lumbar fusion at two year follow-up. Although superiority compared to fusion could not be proved, by comparing clinical symptoms relieved, motion preserved, and the low reoperation rate during long-term follow-up on TDR, TDR was considered safe and effective. Therefore, the authors suggest adopting TDR on a large scale; with failure of TDR, interbody fusion would be performed.
比较经皮脊柱内镜下腰椎间融合术(TDR)与融合术治疗腰椎退行性疾病(LDDD)的疗效和安全性。
通过在 PubMedCentral、MEDLINE、EMBASE、BIOSIS、ClinicalTrials.gov 和 FDA 试验注册中心进行全面检索,获取比较 TDR 与任何其他 LDDD 干预措施的随机对照试验。评估方法学质量并提取相关数据,并进行适当的荟萃分析。两位综述作者独立选择研究、提取数据并评估偏倚风险。将结果和置信区间上限与预先设定的临床相关差异进行比较。
确定了 6 项涉及 1603 名患者的相关随机对照试验(RCT),并报告了两年随访结果。与腰椎融合组相比,TDR 组患者在两年随访时 ODI、VAS 评分和并发症发生率均有显著改善。同时,除前路组的手术时间、后路组的术中出血量、手术时间和再次手术率外,两组间其他指标差异均无临床意义。此外,TDR 后活动度(ROM)保持在正常范围内。
结果表明,TDR 在两年随访时具有与腰椎融合术相当的安全性和疗效。虽然不能证明与融合术相比具有优越性,但通过比较 TDR 在长期随访中缓解临床症状、保留运动功能和低再次手术率,认为 TDR 是安全有效的。因此,作者建议大规模采用 TDR;TDR 失败时,可进行椎间融合术。