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Study Design: A nonrandomized, two-armed prospective study. Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) ( p = .83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p = .61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p = .516). Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.

Study Design Prospective study. Objective Because single-level disk arthroplasty or arthrodesis in the lower subaxial spine improves headaches after surgery, we studied whether this effect may be better appreciated after two-level arthroplasty. Methods We performed an independent post hoc analysis of two concurrent prospective randomized investigational device exemption trials for cervical spondylosis, one for single-level treatment and the other for two adjacent-level treatments. Results For the one-level study, baseline mean headache scores significantly improved at 60 months for both the cervical disk arthroplasty (CDA) and anterior cervical diskectomy and fusion (ACDF) groups ( p Conclusion Both CDA and ACDF at either one or two levels are associated with sustained headache relief from baseline. Patients undergoing two-level arthroplasty had significantly greater improvement in headache at all points except for at 18 and 60 months. This difference in improvement was not observed in patients undergoing single-level arthroplasty. The mechanism of greater headache relief after two-level arthroplasty remains unclear.

IntroductionAnterior cervical discectomy and fusion (ACDF) is one of the most common spinal procedures performed by spine surgeons to treat cervical degenerative disc disease. Use of anterior space...