Robotic guidance (RG) is associated with a lower risk of both surgical complications and revision surgery when compared with fluoroscopic guidance (FG) in adult minimally invasive (MIS) lumbar fusions, a new study has found.
The prospective, multicentre study, MIS ReFRESH, the findings of which were published by Christopher Good (Virginia Spine Institute, Reston, USA) et al in the journal Spine, found that Mazor RG had a 5.8 times lower risk of a surgical complication and 11 times lower risk for revision surgery than FG.
Findings also showed that surgical time between the groups was similar but RG reduced fluoroscopy time per screw by 80%—equating to approximately one minute per case.
Speaking to Spinal News International, Good said: “Over the past few decades, there has been a significant push to incorporate technology to increase the safety of spinal surgical procedures for our patients. Previously, studies have demonstrated that using spinal technology such as navigation and/or robotics leads to increased accuracy for implant placement.
“The MIS ReFRESH study group results are exciting because they focus on the priority outcome—how a patient does after surgery. In comparing patients with traditional fluoroscopic guided minimally invasive surgery versus robotic guided middle invasive surgery, we found a significant decrease in the risk for patients to have complications with surgery or to require a revision (redo) surgery when using robotic guidance as compared to the traditional fluoroscopy.
“We also found a significant decrease in the fluoroscopy time (radiation) used by surgeons to perform the surgery. This has tremendous ramifications not only for patients but also for the operating room team who is exposed to radiation regularly.”
The primary endpoints of the study were the incidence of surgical/wound complications and of revision surgeries, as well as the intraoperative exposure to X-ray radiation during surgery. Patients were analysed at one-year follow-up.
The study included 485 patients from nine sites, with 374 in the RG arm and 111 in the FG arm. In all, 93.2% of patients had more than one-year follow-up. There were no differences between the groups in relation to sex, Charlson Comorbidity Index (CCI), diabetes, or tumour. The mean age of those in the RG cohort was 59 compared with 62.5 in the FG cohort (p=0.009), and body mass index (BMI) was 31.2% vs. 28.1% (p=0.001), respectively. The percentage of smokers was almost double in the RG cohort (15.2% vs. 7.2%; p=0.029).
The researchers found that surgical time was similar (skin-to-skin time/number of screws) at 24.9 minutes (RG) and 22.9 (FG; p=0.550). Fluoroscopy during surgery/number of screws was 15.5 vs. 35.4 seconds respectively, representing an average reduction of 15 seconds, and fluoroscopy time during instrumentation/number of screws was 3.6 seconds vs. 17.8 seconds, showing an 80% average reduction of fluoroscopy time per screw in favour of RG (p<0.001).
Within one-year follow-up, there were 39 (10.4%) surgical complications in the RG cohort compared to 39 (35.1%) in the FG cohort. On top of this, there were eight (2.1%) revisions in the RG cohort vs. seven (6.3%) in the FG cohort. Cox regression analysis including age, sex, BMI, CCI, and number of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher for FG compared to RG (95% confidence interval [CI]: 3.5–9.6, p< 0.001). HR for revision surgery was 11 times higher in the FG cohort compared to RG (95% CI 2.9–41.2, p< 0.001).
Good concluded: “This study reflects my own experience with robotics over the past decade. Prior to the study, I was using both techniques but as we saw the dramatic difference the robotic guidance was making for our patients, I shifted my practice to exclusively using robotic surgery because those patients were doing so much better.
“This prospective multicentre study is a pivotal work and demonstrates to benefits of robotic guidance and serves as a foundation for much broader work and further studies moving forward to increase safety for our patients and increase the chances of a successful surgery.”