MIS-TLIF Versus Open TLIF in Combined Lumbar Stenosis and Low-Grade Spondylolisthesis : Of Discharge Timing and Treatment Pricing.
Aleksandr Krutko, Nikita Kuzmin, Evgeniy Baykov et al.
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In 30 seconds
This open-label, randomised noninferiority trial compared minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) with open TLIF in patients with symptomatic lumbar stenosis and low-grade spondylolisthesis. At three months, the trial did not establish noninferiority for the primary outcome: the mean between-group difference in Oswestry Disability Index reduction was 0.4, with a 90% CI of -5.7 to 6.5, whose lower bound crossed the prespecified noninferiority margin of 12 points. Secondary clinical outcomes and complications did not differ significantly. Open TLIF involved longer hospital stays, while MIS-TLIF had higher direct costs.
Key findings
- The ODI reduction difference was 0.4 (90% CI, -5.7 to 6.5); the confidence interval crossed the 12-point noninferiority margin.
- 82.8% of patients achieved the minimum clinically important difference for ODI.
- Open TLIF was associated with a hospital stay 1.5 days longer (P =0.005) and more frequent additional analgesia (P =0.026).
- Direct costs were 10.5% higher with MIS-TLIF (P <0.001); secondary clinical scales and complications showed no significant group differences.
Why it matters
The findings highlight that similar observed short-term clinical outcomes do not by themselves establish noninferiority when the prespecified statistical criterion is not met. The differences in length of stay, analgesia use, and direct costs also show that procedural choice involves trade-offs beyond clinical scales, which should be interpreted alongside the uncertainty in the primary result.
What to keep in mind
The reported primary outcome is limited to three months. The modified intention-to-treat confidence interval crossed the prespecified noninferiority margin, so noninferiority was not established.