Minimally Invasive, Robotic-vs. Open Fluoroscopic-guided Spinal Instrumented Fusions-a Randomized, Controlled Trial.
Spine (Phila Pa 1976). 2016 Jul 7;
Authors: Hyun SJ, Kim KJ, Jahng TA, Kim HJ
STUDY DESIGN: A prospective randomized clinical trial.
OBJECTIVE: Compare the impact of robotic guidance in a minimally-invasive spine surgery (MIS) to a fluoroscopy-guided, open approach, in lumbar fusions.
SUMMARY OF BACKGROUND DATA: MIS requires a protracted learning curve and excessively exposes the patient and surgical team to harmful radiation. Robotic-guidance has been shown to improve accuracy and radiation in most studies, but there is conflicting prospective data.
METHODS: Patients indicated to undergo a 1 or 2 level spinal fusion were randomized between robotic-guided MIS (RO) and fluoroscopic-guided open surgery (FA). Patient demographics and outcomes were recorded.
RESULTS: Thirty patients were recruited to each arm. Average age was 66.7, 71.5% were females, average BMI was 25.2. Thirty-five levels were instrumented with 130 pedicle screws in RO vs. 40 levels with 140 screws in FA, or 4.3 and 4.7 screws per surgery, respectively. Use of fluoroscopy was 3.5 vs. 13.3?seconds in the RO and FA respectively (p?<?0.001). C-arm output in mSv was 0.13 vs. 0.27 in the RO and FA respectively (p?=?0.015). By thermo-luminescent dosimeters, the average per-screw radiation in the RO arm was 37.5% of that in the FA arm, demonstrating a mean reduction of 62.5% in use of radiation. There was no difference in the improvement in VAS scores for back and leg or the ODI. All screws were accurate in RO while 2 breached (>2?mm and >4?mm) in FA (p?=?0.500). One proximal facet violation occurred in the study, it was in FA (p?=?1.000). The average distance from the proximal facets was 5.8 vs. 4.6?mm in the RO and FA respectively (p?<?0.001). The average length of stay was 6.8 vs. 9.4 days in RO compared with FA (p?=?0.020).
CONCLUSION: MIS using Robotic-guidance significantly reduced radiation exposure and length of stay. Patient outcomes were not affected by the surgical technique.
LEVEL OF EVIDENCE: 1.
PMID: 27398897 [PubMed – as supplied by publisher]