Franke Jörg, Manson Neil, Buzek David, Kosmala Arkadiusz, Hubbe Ulrich, Rosenberg Wout, Pereira Paulo, Assietti Roberto, Martens Frederic, Lam Khai, Barbanti Brodano Giovanni, Durny Peter, Lidar Zvi, Scheufler Kai, Senker Wolfgang
Klinikum Dortmund.
Horizon Health Network.
Cureus. 2016 Jun 13;8(6):e640. doi: 10.7759/cureus.640.
The objective of the study is to assess effectiveness and safety of minimally invasive lumbar interbody fusion (MILIF) for degenerative lumbar disorders (DLD) in daily surgical practice and follow up with patients for one year after surgery. A prospective, multicenter, pragmatic, monitored, international outcome study in patients with DLD causing back/leg pain was conducted (19 centers). Two hundred fifty-two patients received standard of care available in the centers. Patients were included if they were aged >18 years, required one- or two-level lumbar fusion for DLD, and met the criteria for approved device indications. Primary endpoints: time to first ambulation (TFA) and time to surgery recovery (TSR). Secondary endpoints: patient-reported outcomes (PROs)--back and leg pain (visual analog scale), disability (Oswestry Disability Index (ODI)), health status (EQ-5D), fusion rates, reoperation rates, change in pain medication, rehabilitation, return to work, patient satisfaction, and adverse events (AEs). Experienced surgeons (≥30 surgeries pre-study) treated patients with DLD by one- or two-level MILIF and patients were evaluated for one year (NCT01143324). At one year, 92% (233/252) of patients remained in the study.
TFA, 1.3 ±0.5 days and TSR, 3.2 ±2.0 days.
Most patients (83.3%) received one level MILIF; one (two-level) MILIF mean surgery duration, 128 (182) min; fluoroscopy time, 115 (154) sec; blood loss, 164 (233) mL; at one year statistically significant (P<.0001) and clinically meaningful changes from baseline were reported in all PROs--reduced back pain (2.9 ±2.5 vs. 6.2 ±2.3 at intake), reduced leg pain (2.2 ±2.6 vs. 5.9 ±2.8), and ODI (22.4% ± 18.6 vs. 45.3% ± 15.3), as well as health-related quality of life (EQ-5D index: 0.71 ±0.28 vs. 0.34 ±0.32). More of the professional workers were working at one year than those prior to surgery (70.3% vs. 55.2%). Three AEs and one serious AE were considered procedure-related; there were no deep site infections or deaths. This is the first study evaluating MILIF for treatment of DLD in daily clinical practice. Clinically significant improvements were observed in all endpoints. Short-term post-surgery improvements (four weeks) were maintained through one year with minimal complications. Our results suggest that MILIF has good-to-excellent outcomes for the treatment of DLD in a broad patient population under different clinical conditions and healthcare delivery systems.
本研究的目的是在日常手术实践中评估微创腰椎椎间融合术（MILIF）治疗退行性腰椎疾病（DLD）的有效性和安全性，并在术后对患者进行一年的随访。对因DLD导致腰/腿痛的患者开展了一项前瞻性、多中心、实用、有监测的国际结局研究（19个中心）。252例患者接受了各中心现有的标准治疗。纳入标准为年龄>18岁、因DLD需要进行单节段或双节段腰椎融合且符合批准器械适应证标准的患者。主要终点：首次下床活动时间（TFA）和手术恢复时间（TSR）。次要终点：患者报告结局（PROs）——腰腿痛（视觉模拟量表）、残疾程度（Oswestry残疾指数（ODI））、健康状况（EQ-5D）、融合率、再次手术率、止痛药物变化、康复情况、重返工作岗位情况、患者满意度及不良事件（AE）。经验丰富的外科医生（研究前至少进行过30例手术）采用单节段或双节段MILIF治疗DLD患者，并对患者进行一年的评估（NCT01143324）。一年时，92%（233/252）的患者仍在研究中。
TFA为1.3±0.5天；TSR为3.2±2.0天。
大多数患者（83.3%）接受单节段MILIF；单（双）节段MILIF的平均手术时长分别为128（182）分钟；透视时间分别为115（154）秒；失血量分别为164（233）毫升；一年时，所有PROs均报告了具有统计学意义（P<0.0001）且具有临床意义的基线变化——腰痛减轻（入院时为6.2±2.3，一年时为2.9±2.5）、腿痛减轻（入院时为5.9±2.8，一年时为2.2±2.6）、ODI降低（入院时为45.3%±15.3，一年时为22.4%±18.6），以及健康相关生活质量改善（EQ-5D指数：入院时为0.34±0.32，一年时为0.71±0.28）。与术前相比，更多的专业工作人员在一年时恢复了工作（70.3%对55.2%）。3例AE和1例严重AE被认为与手术相关；无深部感染或死亡病例。这是第一项在日常临床实践中评估MILIF治疗DLD的研究。所有终点均观察到具有临床意义的改善。术后短期（四周）改善情况在一年中得以维持，并发症极少。我们的结果表明，在不同临床情况和医疗服务体系下，MILIF在广泛的患者群体中治疗DLD具有良好至优异的疗效。
