Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions: The...

Area of Science:

• Neurosurgery
• Orthopedic Surgery
• Medical Technology

Background:

• Minimally invasive spine surgery (MIS) is advancing, with robotic guidance (RG) emerging as a potential improvement over traditional fluoroscopic guidance (FG).
• The MIS ReFRESH study is the first to directly compare RG and FG techniques in adult MIS lumbar fusions.

Purpose of the Study:

• To assess and compare complication rates, revision surgery rates, and radiation exposure between Mazor robotic-guidance (RG) and fluoro-guidance (FG) in adult MIS lumbar fusions.
• To evaluate the safety and efficacy of robotic guidance in complex spinal procedures.

Main Methods:

• A prospective, multicenter, partially randomized study design.
• Analysis of primary endpoints at 1-year follow-up using Cox logistic regression and Kaplan-Meier survival curves.
• Enrolled 485 patients across nine sites, with 374 in the RG arm and 111 in the FG arm.

Main Results:

• Robotic guidance (RG) demonstrated significantly lower rates of surgical complications (10.4% vs. 35.1% for FG) and revision surgeries (2.1% vs. 6.3% for FG) within 1 year.
• RG reduced fluoroscopy time per screw by 80% (average 15-second reduction per screw) compared to FG, without increasing overall surgical time.
• Cox regression analysis revealed a 5.8 times higher hazard ratio for complications and an 11.0 times higher hazard ratio for revision surgery with FG compared to RG.

Conclusions:

• Mazor robotic-guidance is associated with substantially lower risks of surgical complications and revision surgery in MIS lumbar fusions.
• Robotic guidance offers significant benefits in reducing radiation exposure while maintaining comparable surgical times.
• The findings support the use of robotic guidance as a safer and more effective option for MIS lumbar fusions.