To evaluate the learning curve for exoscope and three-dimensional (3D) 4K hybrid visualization in terms of operating time, advantages, disadvantages, and surgical complications in tubular-access minimally invasive spine surgery (MISS) and to assess surgeon satisfaction with image quality, ergonomics, and ability to perform target site treatment. Overview of Literature: Working through tubular retractors poses a challenge. The extreme angulations during microsurgical decompression, especially contralateral decompression, require surgeons to work non-ergonomically. An exoscope allows surgeons to work ergonomically and independently of the microscope oculars as visualizations are now provided by large 3D 4K monitors. However, the value and efficacy of solely depending on an exoscope and 3D 4K monitors during microsurgical work are still unknown. Methods: Seventy-four patients (99 levels) underwent trans-tubular MISS between March 2018 and January 2019. Five patients were excluded: one had pyogenic discitis, two had revisions, and two were trans-tubular transoral. In total, we analyzed 69 for operating time, blood loss, and complications. The learning curve graph was plotted using the surgical time for each procedure. Surgeons were asked to rate their satisfaction with image quality, ability to maintain ergonomic posture, and efficient target site treatment. Results: For tubular microdiscectomy, the operating time plateaued after six cases, and for tubular decompression and minimally invasive transforaminal lumbar interbody fusion, the operating time plateaued after nine cases. Mean operating time was significantly reduced after the plateau. Complications included four cases of dural tear. All patients improved symptomatically, and there were no postoperative neurological deficits. Conclusions: Use of the exoscope has a short learning curve. Surgeons benefit from improved ergonomic posture during surgery, and resident teaching appears to be good. The only drawback is the need to rearrange the operating table setup. Complications were comparable to those when using the surgical microscope. An exoscope with hybrid digital visualization provides excellent visualization, depth perception, clarity, and precision target site treatment.

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BackgroundSpinal cord injury (SCI) is a devastating condition with limited therapeutic options despite decades of research. Current treatment options include use of steroids, surgery, and rehabilitation. Nevertheless, many patients with SCI remain disabled. MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries and may have a potential role in improving recovery after SCI.ObjectiveThe aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.MethodsSpinal Cord Injury—Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA—International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.ResultsThe coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.ConclusionsSATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.Trial RegistrationClinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG)

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