Siepe Christoph J, Mayer H Michael, Heinz-Leisenheimer Matthias, Korge Andreas
Spine Center, OrthoCenter Munich, Munich, Germany.
Spine (Phila Pa 1976). 2007 Apr 1;32(7):782-90. doi: 10.1097/01.brs.0000259071.64027.04.
Prospective study analyzing midterm clinical results of total lumbar disc replacement (TDR) with ProDisc II performed at different lumbar motion segments.
To assess the influence of the disc level and number of discs replaced following TDR on postoperative outcome.
Multisegmental disc replacement procedures belong to the so-called "off-label" indications for disc replacement, which still lack evidence of noninferiority when compared with fusion procedures. Results from uncontrolled clinical trials regarding monosegmental versus multisegmental disc replacements are contradictory.
The influence of the level and the number of lumbar discs replaced on postoperative outcome was analyzed prospectively according to Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and numerous clinical parameters. Post-TDR pain patterns were analyzed with fluoroscopically guided spine infiltrations.
A total of 99 patients from 3 treatment groups with a mean follow-up of 25.8 months (range, 12.1-57.5 months) achieved significant improvement of preoperative VAS and ODI levels (P < 0.05). Best results and highest patient satisfaction rates (90.9%) were achieved in patients with monosegmental TDR at L4-L5 (n = 22). Results deteriorated when monosegmental TDR was performed at the lumbosacral junction (n = 57) with a tendency toward statistical significance at 24-month follow-up (P = 0.07). Postoperative outcome was significantly inferior following bisegmental disc replacements at L4-L5 + L5-S1 (n = 20) with a considerably higher complication rate when compared with monosegmental TDR procedures. Fluoroscopically guided spine infiltrations confirmed that the incidence of postoperative pain from posterior joint structures was 9.1% (n = 2) for L4-L5 TDR, 28.1% (n = 16) following L5-S1, and 60.0% (n = 12) for bisegmental-TDR at L4-L5 + L5-S1, respectively.
The level and the number of lumbar disc replacements influence postoperative outcome significantly. Satisfactory outcome was achieved for monosegmental L4-L5 and L5-S1 disc replacement procedures with best results achieved following TDR at L4-L5. For bisegmental TDR, complication rates are significantly higher and inferior postoperative results are to be expected. The incidence of postoperative pain originating from facet and/or iliosacral joints is currently underestimated and will require further investigation.
一项前瞻性研究,分析在不同腰椎活动节段进行ProDisc II全腰椎间盘置换术(TDR)的中期临床结果。
评估TDR术后椎间盘节段及置换椎间盘数量对术后疗效的影响。
多节段椎间盘置换手术属于椎间盘置换的所谓“非适应证”,与融合手术相比,仍缺乏不劣于融合手术的证据。关于单节段与多节段椎间盘置换的非对照临床试验结果相互矛盾。
根据视觉模拟量表(VAS)、Oswestry功能障碍指数(ODI)及众多临床参数,前瞻性分析置换腰椎间盘的节段和数量对术后疗效的影响。采用透视引导下脊柱浸润法分析TDR术后疼痛模式。
3个治疗组共99例患者,平均随访25.8个月(范围12.1 - 57.5个月),术前VAS和ODI水平均有显著改善(P < 0.05)。L4 - L5单节段TDR患者(n = 22)取得了最佳疗效和最高患者满意率(90.9%)。腰骶部单节段TDR(n = 57)患者疗效较差,在24个月随访时有统计学意义的趋势(P = 0.07)。L4 - L5 + L5 - S1双节段椎间盘置换术后疗效明显较差,与单节段TDR手术相比,并发症发生率显著更高。透视引导下脊柱浸润法证实,L4 - L5 TDR术后来自后关节结构的疼痛发生率为9.1%(n = 2),L5 - S1术后为28.1%(n = 16),L4 - L5 + L5 - S1双节段TDR术后为60.0%(n = 12)。
置换腰椎间盘的节段和数量对术后疗效有显著影响。L4 - L5和L5 - S1单节段椎间盘置换手术取得了满意的疗效,L4 - L5 TDR术后效果最佳。对于双节段TDR,并发症发生率显著更高,术后疗效较差。目前,源自小关节和/或髂骶关节的术后疼痛发生率被低估,需要进一步研究。