Transforaminal versus posterior lumbar interbody fusion for symptomatic single-level spondylolisthesis (LIFT): a multicentre controlled, patient blinded, randomised non-inferiority trial

Inge J M H Caelers; Ruud Droeghaag; Suzanne L de Kunder; Jasper Most; Kim Rijkers; Ronald H M A Bartels; Jos M A Kuijlen; Mark H H M Hulsbosch; Wouter L W van Hemert; Rob A de Bie; Henk van Santbrink

doi:10.1016/j.lanepe.2024.100964

Transforaminal versus posterior lumbar interbody fusion for symptomatic single-level spondylolisthesis (LIFT): a multicentre controlled, patient blinded, randomised non-inferiority trial

Lancet Reg Health Eur. 2024 Jun 19:43:100964. doi: 10.1016/j.lanepe.2024.100964. eCollection 2024 Aug.

Authors

Inge J M H Caelers^{1

2}, Ruud Droeghaag³, Suzanne L de Kunder⁴, Jasper Most³, Kim Rijkers^{1

2

5}, Ronald H M A Bartels^{6

7}, Jos M A Kuijlen⁸, Mark H H M Hulsbosch⁹, Wouter L W van Hemert³, Rob A de Bie^{10

11}, Henk van Santbrink^{1

2

11}

Affiliations

¹ Department of Neurosurgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands.
² Department of Neurosurgery, Maastricht University Medical Center, Maastricht, the Netherlands.
³ Department of Orthopedic Surgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands.
⁴ Elderly Care, Cicero Zorggroep, Brunssum, the Netherlands.
⁵ School for Mental Health and Neuroscience, Maastricht University, Maastricht, the Netherlands.
⁶ Department of Neurosurgery, Canisius Wilhelmina Hospital Nijmegen, Nijmegen, the Netherlands.
⁷ Department of Neurosurgery, Radboud University Medical Center, Nijmegen, the Netherlands.
⁸ Department of Neurosurgery, University of Groningen, Groningen University Medical Center, Groningen, the Netherlands.
⁹ Department of Orthopedic Surgery, VieCuri Medical Center, Venlo, the Netherlands.
¹⁰ Department of Epidemiology, Maastricht University, Maastricht, the Netherlands.
¹¹ CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands.

Abstract

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: No funding was received for this trial.

Keywords: Effectiveness; Lumbar fusion surgery; Multicenter; Posterior lumbar interbody fusion; Randomized controlled trial; Spondylolisthesis; Transforaminal lumbar interbody fusion.