Robot-assisted minimally invasive versus conventional open transforaminal lumbar interbody fusion for lumbar degenerative disease: a prospective randomized controlled trial
In brief
Robot-assisted lumbar fusion improved disability scores by 3 points at two weeks
In this 128-patient trial, robot-assisted minimally invasive fusion improved two-week disability scores by 3.3 points versus open surgery, a difference below the 10-point target and no longer significant at three months. Screw placement was more accurate and recovery measures favored the robotic approach, but surgery took longer and mid-term clinical outcomes and fusion rates were similar.
- Journal
- Journal of robotic surgery (Q1)
- Published
- 29 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Pengru Wang, Zhilong Shen, Liangwei Ni, Gan Xu, Hao Yuan, Yongxin Mao, et al.
- PMID
- 42955165
- DOI
- 10.1007/s11701-026-04001-4
Why clinicians should know about it
- Picked for Spine Surgery (paper of the day, 30 October 2026): Earlier recovery, higher screw accuracy
Abstract
Robotic guidance may improve pedicle screw placement during minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF), but its clinical value remains uncertain. In this prospective, single-center, assessor-blinded trial, 128 patients were randomly assigned in a prespecified 1:3 ratio to robot-assisted MIS-TLIF (n = 32) or conventional fluoroscopy-guided open TLIF (n = 96) using an independent statistician's computer-generated sequence. The primary outcome was the Oswestry Disability Index (ODI) at 2 weeks. Technical, perioperative, and radiographic outcomes were assessed through 18 months; later assessments were exploratory.At 2 weeks, ODI favored robotic assistance (28.25 ± 6.64 vs 31.52 ± 6.55; mean difference, -3.27; 95% confidence interval, -5.98 to -0.56; P = 0.019), but was below the 10-point sample-size target and nonsignificant at 3 months. Robotic assistance favored grade A screw placement (98.9% vs 94.5%; P = 0.037) and reduced intraoperative adjustment (2.8% vs 7.3%; P = 0.030); facet joint violation and reoperation did not differ significantly. Operative time was longer, whereas blood loss, ambulation, drain removal, and hospital stay favored robotic assistance. Fusion rates and adjacent-segment disc height were similar. Multifidus cross-sectional area was greater with robotic assistance at 12 and 18 months in patients with evaluable imaging. Robot-assisted MIS-TLIF was associated with earlier recovery, higher screw accuracy, and greater postoperative multifidus cross-sectional area, but longer operative time without demonstrated mid-term clinical or fusion benefits. Larger multicenter trials are warranted. Trial Registration:Chinese Clinical Trial Registry, ChiCTR2400082553.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.