Institute for Evaluative Research in Medicine, University of Bern, Stauffacherstrasse 78, 3014 Bern, Switzerland.
BMC Musculoskelet Disord. 2011 Dec 2;12:275. doi: 10.1186/1471-2474-12-275.
Currently, herniated nucleus pulposus (HNP) with radiculopathy and other preconditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). In Switzerland it is left to the surgeon's discretion when to operate. The present study is based on the dataset of SWISSspine, a governmentally mandated health technology assessment registry. We hypothesized that preoperative nucleus pulposus status and presence or absence of radiculopathy has an influence on clinical outcomes in patients treated with mono-segmental lumbar TDR.
Between March 2005 and April 2009, 416 patients underwent mono-segmental lumbar TDR, which was documented in a prospective observational multicenter mode. The data collection consisted of perioperative and follow-up data (physician based) and clinical outcomes (NASS, EQ-5D).Patients were divided into four groups according to their preoperative status: 1) group degenerative disc disease ("DDD"): 160 patients without HNP and no radiculopathy, classic precondition for TDR; 2) group "HNP-No radiculopathy": 68 patients with HNP but without radiculopathy; 3) group "Stenosis": 73 patients without HNP but with radiculopathy, and 4) group "HNP-Radiculopathy": 132 patients with HNP and radiculopathy. The groups were compared regarding preoperative patient characteristics and pre- and postoperative VAS and EQ-5D scores using general linear modeling.
Demographics in all four groups were comparable. Regarding the improvement of quality of life (EQ-5D) there were no differences across the four groups. For the two main groups DDD and HNP-Radiculopathy no differences were found in the adjusted postoperative back- and leg pain alleviation levels, in the stenosis group back- and leg pain relief were lower.
Despite higher preoperative leg pain levels, outcomes in lumbar TDR patients with HNP and radiculopathy were similar to outcomes in patients with the classic indication; this because patients with higher preoperative leg pain levels benefit from a relatively greater leg pain alleviation. The group with absence of HNP but presence of radiculopathy showed considerably less benefits from the operation, which is probably related to ongoing degenerative processes of the posterior segmental structures. This observational multicenter study suggests that the diagnoses HNP and radiculopathy, combined or alone, may not have to be considered as absolute or relative contraindications for mono-segmental lumbar TDR anymore, whereas patients without HNP but with radiculopathy seem to be suboptimal candidates for the procedure.
目前,椎间盘突出症(HNP)伴根性病变和其他前提条件被认为是腰椎全椎间盘置换术(TDR)的相对或绝对禁忌证。在瑞士,何时进行手术由外科医生决定。本研究基于政府要求的健康技术评估登记处 SWISSspine 的数据集。我们假设术前髓核状态和根性病变的存在或不存在会影响接受单节段腰椎 TDR 治疗的患者的临床结果。
2005 年 3 月至 2009 年 4 月,416 例患者接受了单节段腰椎 TDR,采用前瞻性观察性多中心模式进行了记录。数据采集包括围手术期和随访数据(基于医生)和临床结果(NASS、EQ-5D)。根据术前状态,患者分为四组:1)组退行性椎间盘疾病(“DDD”):160 例无 HNP 且无根性病变患者,这是 TDR 的经典适应证;2)组“HNP-无根性病变”:68 例有 HNP 但无根性病变患者;3)组“狭窄”:73 例无 HNP 但有根性病变患者;4)组“HNP-根性病变”:132 例有 HNP 和根性病变患者。使用一般线性模型比较四组患者的术前患者特征以及术前和术后 VAS 和 EQ-5D 评分。
四组患者的人口统计学特征均相似。在生活质量(EQ-5D)改善方面,四组之间没有差异。对于 DDD 和 HNP-根性病变这两个主要组,调整后的术后腰背疼痛缓解水平没有差异,在狭窄组,腰背疼痛缓解水平较低。
尽管术前腿部疼痛水平较高,但 HNP 和根性病变腰椎 TDR 患者的结果与具有经典适应证的患者的结果相似;这是因为术前腿部疼痛水平较高的患者从相对较大的腿部疼痛缓解中获益更多。无 HNP 但有根性病变的组从手术中获益明显较少,这可能与后节段结构的退行性病变有关。这项多中心观察性研究表明,HNP 和根性病变的诊断,无论是单独存在还是合并存在,可能不再被认为是单节段腰椎 TDR 的绝对或相对禁忌证,而无 HNP 但有根性病变的患者似乎不是该手术的理想人选。