■与后路腰椎椎间融合术(PLIF)相比,经椎间孔腰椎椎间融合术(TLIF)在单节段腰椎滑脱患者中的有效性尚未得到证实。为了解决证据差距,一项疗效良好的随机对照非劣效性试验,比较TLIF与PLIF的有效性,题为腰椎椎间融合试验(LIFT),进行了。
■在荷兰五家医院的多中心随机对照非劣效性试验中,161名患者被随机分配到TLIF或PLIF(1:1),根据研究地点分层。患者和统计学家对分组是盲目的。所有患者均超过18岁,有症状的单水平退行性,峡部或医源性腰椎滑脱,并有资格通过后路进行腰椎椎间融合手术。主要结果是使用Oswestry残疾指数(ODI)从术前到术后一年测量的残疾变化。根据ODI的MCID,非劣效性极限设置为7.0分。次要结局是使用EuroQol5Dimensions评估的质量调整生命年(QALY)的变化,5级(EQ-5D-5L)和简短的健康调查(SF-36),以及背部和腿部疼痛(数字评定量表,NRS),焦虑和抑郁(医院焦虑抑郁量表;HADS),围手术期失血,手术持续时间,住院时间,和并发症。审判登记:荷兰审判登记处,编号5722(注册日期2016年3月30日),腰椎椎间融合试验(LIFT):一项手术治疗腰椎滑脱的随机对照多中心试验。
■患者在2017年8月至2020年11月期间纳入。总研究人群为161名患者。一年后的总随访损失为16例。按照方案分析包括每组66名患者。在TLIF组中(平均年龄61.6,女性36),ODI从46.7提高到20.7,而在PLIF组(平均年龄61.9,41名女性),从46.0提高到24.9。这种差异(-4.9,90%CI-12.2至+2.4)未达到ODI中7.0分的非劣效性极限。次要结果测量有显著差异,QALY(SF-36),观察到有利于TLIF(P<0.05)。然而,这与临床无关.所有其他次要结局测量结果均无差异;PROM(EQ-5D,NRS腿/背部,HADS),围手术期失血,手术持续时间,住院时间,围手术期及术后并发症。
■对于单级脊椎滑脱患者,TLIF在临床有效性方面不劣于PLIF。两组之间的残疾(用ODI测量)随时间没有差异。
■本试验未收到资助。
UNASSIGNED: The effectiveness of transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar interbody fusion (PLIF) in patients with single-level
spondylolisthesis has not been substantiated. To address the evidence gap, a well-powered randomized controlled non-inferiority trial comparing the effectiveness of TLIF with PLIF, entitled the Lumbar Interbody Fusion Trial (LIFT), was conducted.
UNASSIGNED: In a multicenter randomized controlled non-inferiority trial among five Dutch hospitals, 161 patients were randomly allocated to either TLIF or PLIF (1:1), stratified according to study site. Patients and statisticians were blinded for group assignment. All patients were over 18 years old with symptomatic single-level degenerative, isthmic or iatrogenic lumbar
spondylolisthesis, and eligible for lumbar interbody fusion surgery through a posterior approach. The primary outcome was change in disability measured with the Oswestry Disability Index (ODI) from preoperative to one year postoperative. The non-inferiority limit was set to 7.0 points based on the MCID of ODI. Secondary outcomes were change in quality-adjusted life years (QALY) assessed with EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) and Short Form Health Survey (SF-36), as well as back and leg pain (Numerical rating scale, NRS), anxiety and depression (Hospital Anxiety Depression Scale; HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and complications. Trial registration: Netherlands Trial Registry, number 5722 (registration date March 30, 2016), Lumbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar
spondylolisthesis.
UNASSIGNED: Patients were included between August 2017 and November 2020. The total study population was 161 patients. Total loss-to-follow-up after one year was 16 patients. Per-protocol analysis included 66 patients in each group. In the TLIF group (mean age 61.6, 36 females), ODI improved from 46.7 to 20.7, whereas in the PLIF group (mean age 61.9, 41 females), it improved from 46.0 to 24.9. This difference (-4.9, 90% CI -12.2 to +2.4) did not reach the non-inferiority limit of 7.0 points in ODI. A significant difference in the secondary outcome measurement, QALY (SF-36), was observed in favor of TLIF (P < 0.05). However, this was not clinically relevant. No difference was found for all other secondary outcome measurements; PROMs (EQ-5D, NRS leg/back, HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and perioperative and postoperative complications.
UNASSIGNED: For patients with single-level
spondylolisthesis, TLIF is non-inferior to PLIF in terms of clinical effectiveness. Disability (measured with ODI) did not differ over time between groups.
UNASSIGNED: No funding was received for this trial.