Artikel
Minimally invasive, robotic- vs. open fluoroscopic-guided spinal instrumented fusions – a randomized, controlled trial
Suche in Medline nach
Autoren
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Seung-Jae Hyun
- Seoul National University Bundang Hospital, Seoul National University College of Medicine
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Ki-Jeong Kim
- Seoul National University Bundang Hospital, Seoul National University College of Medicine
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Tae-Ahn Jahng
- Seoul National University Bundang Hospital, Seoul National University College of Medicine
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Hyun-Jib Kim
- Seoul National University Bundang Hospital, Seoul National University College of Medicine
| Veröffentlicht: | 8. Juni 2016 |
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Gliederung
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Objective: Minimally-invasive spine surgery (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. To compare the impact of robotic guidance in a minimally invasive approach to a fluoroscopy-guided, open approach, in lumbar fusions.
Method: This single-center, prospective, randomized (1:1) study, recruited adult patients with single- or double-level degenerative lumbar disorders scheduled to undergo primary lumbar interbody fusion during the period of December 2013 to January 2015. Patients were randomly allocated, using blinded randomization blocks, between robot-guided surgery in a minimally invasive approach, and traditional open surgery, with fluoroscopy assistance. The study is registered on CRiS (WHO) as KCT0000993. The local ethical committee approved this study. (IRB No.: B-1311/228-008)
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. Operative time was 208.5 minutes in both groups. 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). 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 (>2mm and >4mm) 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 in the RO and FA respectively (p<0.001). The average length of stay was 6.8 vs. 9.4 in RO compared with FA (p=0.020).
Conclusions: Robotic-guidance significantly reduced radiation exposure and length of stay. Patient outcomes were not affected by the surgical technique.
