Leahy Michael, Zigler Jack E, Ohnmeiss Donna D, Rashbaum Ralph F, Sachs Barton L
Texas Back Institute Research Foundation, Plano, TX 75093, USA.
Spine (Phila Pa 1976). 2008 Jul 1;33(15):1690-3; discussion 1694-5. doi: 10.1097/BRS.0b013e31817bd2f0.
Data for this study were collected as part of a prospective Food and Drug Administration regulated IDE trial for the ProDisc total disc replacement.
The purpose of the study was to compare the results of total disc replacement (TDR) in patients with previous discectomy to patients who had no such previous surgery.
Discectomy is a well accepted surgical procedure for appropriately selected patients. However, removal of a portion of the disc may lead to further disc degeneration and collapse of the disc space. In the past, treatment options for such patients included a variety of fusion procedures, particularly ones incorporating an interbody graft to restore disc space height. Currently, TDR is being used to treat symptomatic disc degeneration. The results of this procedure have not been specifically investigated in patients with previous discectomy.
Data were drawn from 1 center participating in the IDE trial for ProDisc. Only patients reaching the 24-month follow-up period were included. Patients were divided into 2 subgroups: those who had previously undergone lumbar discectomy (N = 20) and those who had not (N = 67). Data for this study were collected prospectively before surgery, and at 6 weeks, 3, 6, 12, 18, and 24 months after surgery. The primary outcome measures used were visual analog scales (VAS) assessing pain, Oswestry questionnaire, postoperative patient satisfaction measured on a 0 to 10 VAS, and asking patients if they would have the same procedure again. The outcome measures were compared between the 2 subgroups.
The results of this study found no differences between the 2 groups based on any of the 4 outcome measures used at any of the follow-up periods (all P > 0.10). Both groups improved significantly from the preoperative baseline on the VAS assessing pain and the Oswestry questionnaire. The mean satisfaction scores were greater than 7.5 at all follow-up periods and more than 80% of patients in both groups indicated that they would have the same surgery again.
The results of this study indicate that the outcome of TDR is not compromised among patients witha history of previous discectomy. This finding supports TDR as a viable treatment for patients with symptomatic disc degeneration arising from a previously operated lumbar disc.
本研究的数据收集自一项前瞻性、由美国食品药品监督管理局监管的关于ProDisc全椎间盘置换术的器械临床试验（IDE）。
本研究旨在比较曾接受椎间盘切除术的患者与未曾接受此类手术的患者进行全椎间盘置换（TDR）的结果。
对于经过适当选择的患者，椎间盘切除术是一种广泛接受的外科手术。然而，切除部分椎间盘可能会导致椎间盘进一步退变以及椎间隙塌陷。过去，此类患者的治疗选择包括多种融合手术，特别是那些采用椎间融合器来恢复椎间隙高度的手术。目前，TDR正被用于治疗有症状的椎间盘退变。但此前未曾专门研究过在曾接受椎间盘切除术的患者中该手术的效果。
数据取自参与ProDisc IDE试验的1个中心。仅纳入达到24个月随访期的患者。患者被分为2个亚组：曾接受过腰椎间盘切除术的患者（N = 20）和未接受过该手术的患者（N = 67）。本研究的数据在术前以及术后6周、3个月、6个月、12个月、18个月和24个月前瞻性收集。所使用的主要结局指标包括评估疼痛的视觉模拟量表（VAS）、Oswestry问卷、用0至10分的VAS测量术后患者满意度以及询问患者是否愿意再次接受相同手术。对这2个亚组的结局指标进行比较。
本研究结果发现在任何随访期，基于所使用的4项结局指标中的任何一项，两组之间均无差异（所有P > 0.10）。在评估疼痛的VAS和Oswestry问卷方面两组均较术前基线有显著改善。在所有随访期平均满意度得分均大于7.5分，两组中超过80%的患者表示他们愿意再次接受相同手术。
本研究结果表明，对于有椎间盘切除术史的患者，TDR的结局并未受到影响。这一发现支持TDR作为治疗既往接受过手术的腰椎间盘所致有症状椎间盘退变患者的一种可行治疗方法。
