尽管有证据表明其安全性和有效性,腰椎间盘关节置换术的应用一直在缓慢扩展,部分原因是担心晚期并发症和与早期器械相关的翻修手术的风险.最近,FDA对新设备的批准和改善报销已经扭转了美国的这一趋势。仍需要有关腰椎间盘置换术的其他长期数据。本研究报告了美敦力脊柱和生物制品\'Maverick全椎间盘置换的FDA研究设备豁免临床试验的5年结果。
从L4到S1的单级退行性椎间盘疾病患者在31个研究地点以2:1随机分组。在2003年4月至2004年8月期间,405例患者接受了研究设备,172例患者接受了前路腰椎椎间融合术的控制程序。成果衡量标准包括Oswestry残疾指数(ODI),背部和腿部疼痛的数字评定量表(NRS),SF-36,光盘高度,身体间运动,异位骨化(研究装置),不良事件(AE),额外的手术,和神经状态。当满足以下所有标准时,治疗被认为是总体成功:1)ODI评分比术前评分提高≥15分;2)与术前相比,神经状态维持或改善;3)椎间盘高度成功,也就是说,前高度或后高度减少不超过2-mm;4)没有由植入物或植入物和外科手术引起的严重AE;5)没有被归类为失败的额外手术。
与对照组相比,根据ODI和SF-36物理成分汇总(PCS),1年,2年和5年,1年和2年的背痛NRS和1年的腿痛NRS,研究组的改善在统计学上更大.异位骨化率随着时间的推移而增加:1年时为1.0%(4/382),2.6%(9/345)在2年,5年为5.9%(11/187)。在术后2年和5年,与对照组患者相比,研究患者的装置相关AE和严重的装置相关AE较少。在所有随访间隔中都证明了复合措施总体成功的非劣效性;在1年和2年证明了优越性。
腰椎间盘关节置换术是治疗单节段腰椎间盘退变性疾病的一种安全有效的方法,导致改善身体功能和减少疼痛长达5年后的手术。临床试验登记号.:NCT00635843(临床试验)。
Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics\' Maverick total disc replacement.
Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.
Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.
Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.Clinical trial registration no.: NCT00635843 (clinicaltrials.gov).