Robot-assisted minimally invasive versus conventional open transforaminal lumbar interbody fusion for lumbar degenerative disease: a prospective randomized controlled trial.
Pengru Wang, Zhilong Shen, Liangwei Ni et al.
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In 30 seconds
This prospective, single-centre, assessor-blinded randomized trial compared robot-assisted minimally invasive TLIF with conventional fluoroscopy-guided open TLIF in 128 patients with lumbar degenerative disease. 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), although the difference was below the prespecified 10-point sample-size target and was not significant at 3 months. Robotic assistance also improved screw-placement accuracy and reduced intraoperative adjustment, but operative time was longer and no mid-term clinical or fusion benefit was demonstrated.
Key findings
- At 2 weeks, ODI was 28.25 ± 6.64 with robotic assistance versus 31.52 ± 6.55 with open TLIF (mean difference, -3.27; 95% confidence interval, -5.98 to -0.56; P = 0.019).
- Grade A screw placement was more frequent with robotic assistance (98.9% vs 94.5%; P = 0.037), and intraoperative adjustment was less frequent (2.8% vs 7.3%; P = 0.030).
- Operative time was longer with robotic assistance; blood loss, ambulation, drain removal, and hospital stay favored it, while fusion rates were similar.
- Multifidus cross-sectional area was greater with robotic assistance at 12 and 18 months among patients with evaluable imaging.
Why it matters
The trial separates technical accuracy from patient-important benefit: robotic guidance improved screw placement and some perioperative measures, but the early ODI difference was modest relative to the prespecified target and did not persist at 3 months. These findings help frame the potential trade-off between improved procedural metrics and longer operative time, while leaving mid-term clinical and fusion advantages unestablished.
What to keep in mind
The trial was single-centre, and the 2-week ODI difference was below the 10-point sample-size target. Later assessments were exploratory, and multifidus findings were limited to patients with evaluable imaging.