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Mazda K. Turel, Mena G. Kerolus, Owoicho Adogwa, and Vincent C. Traynelis

OBJECTIVE

The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published.

METHODS

The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed.

RESULTS

In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success.

CONCLUSIONS

This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

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Mazda K. Turel, Mena G. Kerolus, and John E. O’Toole

Ossification of the ligament flavum in the thoracic spine is an uncommon radiological finding in the Western population but can present with back pain, varying degrees of myelopathy, and even paraplegia on occasion. The authors here present the case of a 50-year-old woman with a history of progressive back pain and symptoms of spontaneous intracranial hypotension who was found to have an ossified ligamentum flavum of the thoracic spine resulting in a dural erosion cerebrospinal fluid leak. Surgery involved removal of the ossified ligament flavum at T10–11, facetectomy, ligation of the nerve root, and primary closure of the dura, which resulted in complete resolution of the patient’s symptoms. Radiological, clinical, and intraoperative findings are discussed to assist surgeons with an accurate diagnosis and treatment in the setting of this unusual presentation.

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Mena G. Kerolus, Joonho Chung, Stephen A. Munich, Yoshikazu Matsuda, Hideo Okada, and Demetrius K. Lopes

Transvenous embolization is an effective method for treating dural arteriovenous fistulas (DAVFs) of the transverse-sigmoid sinus (TSS). However, in cases of complicated DAVFs, it is difficult to preserve the patency of the dural sinus. The authors describe the technical details of a new reconstructive technique using transvenous balloon-assisted Onyx embolization as another treatment option in a patient with an extensive and complex DAVF of the left TSS.

A microcatheter and compliant balloon catheter were navigated into the left internal jugular vein and placed at the distal end of the DAVF in the transverse sinus. The microcatheter was placed between the vessel wall of the TSS and the balloon. After the balloon was fully inflated, Onyx-18 was injected at the periphery of the balloon in a slow, controlled, progressive, stepwise manner; the balloon and microcatheter were simultaneously withdrawn toward the sigmoid sinus, with Onyx encompassing the entirety of the complex DAVF. The Onyx refluxed into multiple arterial feeders in a distal-to-proximal step-by-step manner, ultimately resulting in an Onyx tunnel. The final angiography study revealed complete obliteration of the DAVF and patency of the TSS.

The Onyx tunnel, or reconstructive transvenous balloon-assisted Onyx embolization technique, may be an effective treatment option for large, complex DAVFs of the TSS. This technique may provide another option to facilitate the complete obliteration of the DAVF while preserving the functional sinus.

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Josha Woodward, Hani Malone, Christopher D. Witiw, John Paul G. Kolcun, Lacin Koro, Kevin C. Keegan, Shahjehan Ahmad, Mena G. Kerolus, Brian T. David, R. David Fessler, and Richard G. Fessler

OBJECTIVE

The goal of this study was to evaluate the clinical and radiographic outcomes of a novel multidirectional in situ expandable minimally invasive surgery (MIS) transforaminal lumbar interbody fusion (TLIF) cage.

METHODS

A retrospective analysis of 69 consecutive patients undergoing a 1- or 2-level MIS TLIF using an expandable cage was performed over a 2-year period. Standard MIS techniques with pedicle screw fixation were used in all cases. Upright lateral dynamic flexion/extension radiographs were reviewed prior to and at 1 year after surgery. Clinical metrics included numeric rating scale for back and leg pain, Oswestry Disability Index, and the SF-12 and VR-12 physical and mental health surveys. Radiographic parameters included anterior and posterior disc height, neuroforaminal height, spondylolisthesis, segmental lordosis, lumbar lordosis, and fusion rate.

RESULTS

A total of 69 patients representing 75 operative levels met study inclusion criteria. The mean patient age at surgery was 63.4 ± 1.2 years, with a female predominance of 51%. The average radiographic and clinical follow-ups were 372 and 368 days, respectively. A total of 63 patients (91%) underwent 1-level surgery and 6 patients (9%) underwent 2-level surgery. Significant reductions of numeric rating scale scores for back and leg pain were observed—from 6.1 ± 0.7 to 2.5 ± 0.3 (p < 0.0001) and 4.9 ± 0.6 to 1.9 ± 0.2 (p < 0.0001), respectively. A similar reduction in Oswestry Disability Index from 38.0 ± 4.6 to 20.0 ± 2.3 (p < 0.0001) was noted. Likewise, SF-12 and VR-12 scores all showed statistically significant improvement from baseline (p < 0.001). The mean anterior and posterior disc heights improved from 8.7 ± 1.0 mm to 13.4 ± 1.5 mm (p = 0.0001) and 6.5 ± 0.8 mm to 9.6 ± 1.1 mm (p = 0.0001), respectively. Neuroforaminal height improved from 17.6 ± 2.0 mm to 21.9 ± 2.5 mm (p = 0.0001). When present, spondylolisthesis was, on average, reduced from 4.3 ± 0.5 mm to 1.9 ± 0.2 mm (p = 0.0001). Lumbar lordosis improved from 47.8° ± 5.5° to 58.5° ± 6.8° (p = 0.2687), and no significant change in segmental lordosis was observed. The overall rate of radiographic fusion was 93.3% at 1 year. No perioperative complications requiring operative revision were encountered.

CONCLUSIONS

In this series of MIS TLIFs, use of this novel interbody cage was shown to be safe and effective. Significant improvements in pain and disability were observed. Effective and durable restoration of disc height and neuroforaminal height and reduction of spondylolisthesis were obtained, with concurrent gains in lumbar lordosis. Taken together, this device offers excellent clinical and radiographic outcomes via an MIS approach.