Richter Alexander, Halm Henry F H, Hauck Michael, Quante Markus
*Spine Center Hamburg, Asklepios Klinik St. Georg, Hamburg, Germany †Department of Spine Surgery and Scoliosis Center, Klinikum Neustadt, Neustadt i. H ‡Institute of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
J Spinal Disord Tech. 2014 Aug;27(6):336-41. doi: 10.1097/BSD.0b013e31825f7203.
Two-arm prospective controlled study.
The aim of our study was to prospectively assess the outcome of symptomatic lumbar spinal stenosis (LSS) treated with decompressive surgery alone in comparison with additional implantation of the Coflex interspinous device.
In symptomatic LSS, decompression surgery is an established treatment. Recently, a number of interspinous devices have been introduced as an alternative to conventional surgical procedures. The theoretical aim of the Coflex device is to unload the facet joints, restore foraminal height, and provide stability to improve the clinical outcome. Published information is limited, and there are no data that prove the superiority of the implant in comparison with traditional surgical approaches.
Sixty-two patients with symptomatic LSS were treated with decompressive surgery; 31 of these patients received an additional Coflex device. Preoperatively and postoperatively, disability and pain scores were measured using the Oswestry Disability Index, the Roland-Morris Disability Questionnaire, the Visual Analog Scale, and the pain-free walking distance. Patients underwent postoperative assessments at 3, 6, 12, and 24 month including the above-mentioned scores and patient satisfaction.
There was a significant improvement (P<0.001) in the clinical outcome assessed in the Oswestry Disability Index, the Roland-Morris Disability Questionnaire, the Visual Analog Scale, and the pain-free walking distance at all times of reinvestigation compared with the base line in both groups. Up to 2 years after surgery, there were no significant differences between both groups in all ascertained parameters, including the patient satisfaction and subjective operation decision.
The results of this first prospective controlled study indicate that the additional placement of a Coflex interspinous device does not improve the already good clinical outcome after decompressive surgery for LSS in the 24-month follow-up interval.
双臂前瞻性对照研究。
我们研究的目的是前瞻性评估单纯减压手术与额外植入Coflex棘突间装置治疗症状性腰椎管狭窄症（LSS）的疗效。
在症状性LSS中，减压手术是一种既定的治疗方法。最近，一些棘突间装置已被引入作为传统手术方法的替代方案。Coflex装置的理论目标是减轻小关节负荷、恢复椎间孔高度并提供稳定性以改善临床疗效。已发表的信息有限，且没有数据证明该植入物相对于传统手术方法的优越性。
62例症状性LSS患者接受了减压手术；其中31例患者额外植入了Coflex装置。术前和术后，使用Oswestry功能障碍指数、罗兰-莫里斯功能障碍问卷、视觉模拟量表和无痛步行距离来测量功能障碍和疼痛评分。患者在术后3、6、12和24个月接受评估，包括上述评分和患者满意度。
与基线相比，两组在所有复查时间点的Oswestry功能障碍指数、罗兰-莫里斯功能障碍问卷、视觉模拟量表和无痛步行距离评估的临床疗效均有显著改善（P<0.001）。术后长达2年，两组在所有确定的参数上均无显著差异，包括患者满意度和主观手术决策。
这项首次前瞻性对照研究的结果表明，在24个月的随访期内，额外植入Coflex棘突间装置并不能改善LSS减压手术后本已良好的临床疗效。
