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Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions: The
Christopher R Good1, Lindsay Orosz2, Samuel R Schroerlucke3
1Virginia Spine Institute, Reston, VA.
Study Design:
Prospective, multicenter, partially randomized.
Objective:
Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG).
Summary Of Background Data:
Minimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions.
Methods:
Primary endpoints were analyzed at 1 year follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications.
Results:
Nine sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had more than 1 year f/u. There were no differences for sex, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 versus 62.5 for FG (P = 0.009) and body mass index (BMI) was 31.2 versus 28.1 (P< 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, P = 0.029). Surgical time was similar (skin-to-skin time/no. of screws) at 24.9 minutes RG and 22.9 FG (P = 0.550). Fluoroscopy during surgery/no. of screws was 15.5 seconds RG versus 35.4 seconds FG, (15 seconds average reduction). Fluoroscopy time during instrumentation/no. of screws was 3.6 seconds RG versus 17.8 seconds FG showing an 80% average reduction of fluoro time/screw in RG (P < 0.001). Within 1 year follow-up, there were 39 (10.4%) surgical complications RG versus 39 (35.1%) FG, and 8 (2.1%) revisions RG versus 7 (6.3%) FG. Cox regression analysis including age, sex, BMI, CCI, and no. of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher FG versus RG (95% CI: 3.5-9.6, P < 0.001). HR for revision surgery was 11.0 times higher FG versus RG cases (95% CI 2.9-41.2, P < 0.001).
Conclusion:
Mazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately 1 min/case).Level of Evidence: 2.
Insights
Mazor robotic-guidance significantly lowers complication and revision surgery risks in minimally invasive lumbar fusions compared to fluoro-guidance. Robotic assistance also reduces radiation exposure without increasing surgical time.
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.
