Spine Center Hamburg, Asklepios Klinik St. Georg, Hamburg, Germany.
Eur Spine J. 2010 Feb;19(2):283-9. doi: 10.1007/s00586-009-1229-9. Epub 2009 Dec 5.
A number of interspinous process devices have recently been introduced to the lumbar spinal market as an alternative to conventional surgical procedures in the treatment of symptomatic lumbar stenosis. One of those "dynamic" devices is the Coflex device which has been already implanted worldwide more than 14,000 times. The aim of implanting this interspinous device is to unload the facet joints, restore foraminal height and provide stability in order to improve the clinical outcome of surgery. Published information is limited, and there are so far no data of comparison between the implant and traditional surgical approaches such as laminotomy. The purpose of our prospective study is to evaluate the surgical outcome of decompressive surgery in comparison to decompressive surgery and additional implantation of the Coflex interspinous Device. 60 patients who were all treated in the Spine Center of Klinikum Neustadt, Germany for a one or two level symptomatic LSS with decompressive surgery were included. Two groups were built. In Group one (UD) we treated 30 patients with decompression surgery alone and group two (CO) in 30 patients a Coflex device was additional implanted. Pre- and postoperatively disability and pain scores were measured using the Oswestry disability index (ODI), the Roland-Morris score (RMS), the visual analogue scale (VAS) and the pain-free walking distance (WD). Patients underwent postoperative assessments 3, 6 and 12 month including the above-mentioned scores as well as patient satisfaction. In both groups we could see a significant improve (p < 0.001) in the clinical outcome assessed in the ODI, in the RMS for evaluation of back pain, in the VAS and in the pain-free WD at all times of reinvestigation compared to base line. At 1-year follow up there were no statistically differences between both groups in all ascertained parameters including patient satisfaction and subjective operation decision. Because there is no current evidence of the efficacy of the Coflex device we need further data from randomized controlled studies for defining the indications for theses procedures. To the best of our knowledge this is the first prospective controlled study which compares surgical decompression of lumbar spinal stenosis with additional implanting of an interspinous Coflex device in the treatment of symptomatic LSS.
最近，一些棘突间装置已被引入腰椎脊柱市场，作为治疗症状性腰椎狭窄症的传统手术方法的替代方案。其中一种“动态”装置是 Coflex 装置，该装置已在全球范围内植入超过 14000 次。植入这种棘突间装置的目的是减轻小关节的负荷，恢复椎间孔高度，并提供稳定性，以改善手术的临床效果。已发表的信息有限，目前还没有关于该植入物与传统手术方法（如椎板切开术）之间的比较数据。我们的前瞻性研究旨在评估减压手术的手术结果，与减压手术和额外植入 Coflex 棘突间装置的手术结果进行比较。60 名患者均因单节段或双节段有症状的 LSS 接受减压手术治疗，被纳入德国 Klinikum Neustadt 脊柱中心的研究。建立了两组。在第 1 组（UD）中，我们单独治疗了 30 例患者，在第 2 组（CO）中，30 例患者额外植入了 Coflex 装置。使用 Oswestry 功能障碍指数（ODI）、Roland-Morris 评分（RMS）、视觉模拟量表（VAS）和无痛步行距离（WD）来测量术前和术后的残疾和疼痛评分。患者在术后 3、6 和 12 个月进行了评估，包括上述评分以及患者满意度。在两组中，我们都发现临床结果在 ODI 、评估腰痛的 RMS 、VAS 和无痛 WD 方面都有显著改善（p < 0.001），与基线相比，在所有再检查时都有显著改善。在 1 年随访时，两组在所有确定的参数（包括患者满意度和主观手术决策）方面均无统计学差异。由于目前没有 Coflex 装置疗效的证据，我们需要进一步的随机对照研究数据来确定这些手术的适应证。据我们所知，这是第一项比较腰椎脊柱狭窄症减压手术与附加植入棘突间 Coflex 装置治疗症状性 LSS 的前瞻性对照研究。
