Robot-assisted minimally invasive versus conventional open transforaminal lumbar interbody fusion for lumbar degenerative disease: a prospective randomized controlled trial

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.