Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.

Towards a More Simplified Approach for Evaluating Strength of Evidence in Health Technology Assessments.

It is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of a new medical device prior to the widespread adoption of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. Even though dozens of organizations perform HTAs, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA. Thus, there are considerable discrepancies in the methodologies among HTAs such that the same device with the same underlying clinical evidence is often endorsed by one agency but not another, leading to inconsistencies in healthcare coverage policy decisions. Here, we propose a more simplified and unified approach for summarizing clinical effectiveness and safety outcomes for HTAs. We developed a short, semi-quantitative scoring tool that can be used to provide an overall evaluation of evidence strength in HTAs consisting of five categories: (a) the number of randomized controlled trials (RCTs) that have been performed using the technology, (b) the risk of bias among RCTs, (c) the effect size observed for the key effectiveness outcome, (d) the effect size observed for the key safety outcome, and (e) the generalizability of outcomes observed in RCTs to those observed in real-world clinical use. Utilization of this simplified semi-quantitative framework may simplify the HTA process and improve the consistency of the resulting recommendations.

Arachnoiditis ossificans of the thoracic spine.

Arachnoiditis ossificans is a rare disorder characterized by the development of calcifications of the arachnoid membrane of the thoracic and lumbar spines. It is an extremely rare cause of spinal canal stenosis and consequent neurological compromise, and its origins and optimal management remain unclear. We review of the literature that illustrates the challenges of diagnosis and treatment of arachnoiditis ossificans. A patient with arachnoiditis ossificans is discussed to illustrate the presentation, treatment, and prognosis of the disease.

Timing of tracheostomy after anterior cervical spine fixation.

BACKGROUND: Patients with cervical spinal cord injury frequently undergo early anterior cervical spine fixation (ACSF) and tracheostomy procedures to reduce further deterioration, to reduce risk of pulmonary complications, and to improve patient mobilization. However, tracheostomy is often delayed because of the risk of cross contamination as a result of the proximity to the ACSF incision site. Currently, there is a paucity of studies evaluating this outcome to determine the safety of early tracheostomy after ACSF. In this study, we have evaluated the outcomes and complications associated with early tracheostomy placement. METHODS: We performed a retrospective review of all patients who underwent tracheostomy placement and ACSF during the same hospitalization between 2005 and 2010. A variety of patient and procedural data were collected, including demographics, timing of ACSF and tracheostomy, length of hospitalization, indication for surgery, American Spinal Injuries Association and Glasgow Coma Scale scores on admission, reason for tracheostomy, method of tracheostomy, and complications. RESULTS: Of the 1,184 patients who underwent an ACSF, 20 (1.7%) required a postfixation tracheostomy. Tracheostomy was performed at mean (SD) of 6.9 (4.2) days after ACSF, ranging from 0 to 17 days. Although nearly half of all patients underwent postfixation tracheostomy within 6 days, no wound or implant infection was seen to occur in any patient. Ten patients (50%) developed ventilator-associated pneumonia, with most cases occurring before tracheostomy (90% vs. 10%, p < 0.0001). Univariate analysis only revealed late tracheostomy to significantly increase the risk of complications (odds ratio, 9.33; 95% confidence interval, 1.19-73.0; p = 0.033). Analysis of all studies in the literature revealed a 1% cross-infection rate, with no cases involving implant contamination. CONCLUSION: Our findings suggest that early tracheostomy can be performed safely after cervical spine fixation surgery, with no patients developing incisional or implant infections. As the risk of cross contamination is only 1%, early tracheostomy should be strongly considered because of its potential benefits. LEVEL OF EVIDENCE: Therapeutic/care management, level IV.

Thickness of subcutaneous fat as a risk factor for infection in cervical spine fusion surgery.

BACKGROUND: Surgical site infections increase the incidence of morbidity and mortality as well as health-care expenses. The cost of care increases threefold to fourfold as a consequence of surgical site infection after spinal surgery. The aim of the present study was to determine the role of subcutaneous fat thickness in the development of surgical site infection following cervical spine fusion surgery. METHODS: We performed a retrospective review of a consecutive cohort of 213 adult patients who underwent posterior cervical spine fusion between 2006 and 2008 at Duke University Medical Center. The horizontal distance from the lamina to the skin surface at the C5 level and the thickness of subcutaneous fat were measured, and the ratio of the fat thickness to the total distance at the surgical site was determined. Previously identified risk factors for the development of surgical site infection were also recorded. RESULTS: Twenty-two of the 213 patients developed a postoperative infection. Obesity (body mass index ≥ 30 kg/m2) was not a significant risk factor for surgical site infection; the body mass index (and 95% confidence interval) was 29.4 ± 1.2 kg/m2 in the patients who developed a surgical site infection compared with 28.9 ± 0.94 kg/m2 in the patients without an infection. However, the thickness of subcutaneous fat and the ratio of the fat thickness to the lamina-to-skin distance were both significant risk factors for infection. The thickness of subcutaneous fat was 27.0 ± 2.5 mm in the patients who developed a surgical site infection group compared with 21.4 ± 0.88 mm in the patients without an infection (p = 0.042). The ratio of fat thickness to total thickness was 0.42 ± 0.019 in the patients who developed a surgical site infection compared with 0.35 ± 0.01 in the patients without an infection (p = 0.020). Multivariate analysis revealed this ratio to be an independent risk factor for developing a postoperative infection (odds ratio, 3.18; 95% confidence interval, 1.02 to 9.97). CONCLUSIONS: The study demonstrated that the thickness of subcutaneous fat at the surgical site is a factor in the development of surgical site infection following cervical spine fusion and deserves assessment in the preoperative evaluation.

Dorsal thoracic spinal cord herniation: report of an unusual case and review of the literature.

BACKGROUND CONTEXT: Spinal cord herniation is a rare but well-documented condition that has been associated with tethering through the dural defect. Both spinal cord herniation and cord tethering result in progressive myelopathy that can be improved or stabilized with surgical intervention. Most cases of herniation are caused by dural defects in the ventral or ventrolateral thoracic spine, rarely occurring through the dorsal dura. This is the first reported case of a spontaneous dorsal herniation. PURPOSE: To describe a unique case of thoracic tethered cord resulting from a dorsal dural defect through which there is spinal cord herniation. STUDY DESIGN: A case report and review of the literature. METHODS: A 55-year-old man presented with progressive low back pain, paresthesias, and weakness in his left lower extremity that was exacerbated by walking. Imaging revealed a dorsal dural defect with tethering and herniation of the spinal cord at T7. RESULTS: The patient underwent a T6-T7 laminoplasty to release the tethered cord and repair the dural defect. At 1-year follow-up, the patient noted improvement in strength and back spasticity. CONCLUSIONS: Spinal cord herniation through a dural defect is an uncommon but important cause of symptomatic tethered cord in adults. Surgical intervention can significantly alter the course and prevent further disability.

Drug overdose resulting in quadriplegia.

PURPOSE: To describe a case of cervical flexion myelopathy resulting from a drug overdose. METHODS: A 56-year-old male presented to the emergency department unable to move his extremities following drug overdose. Neurological examination revealed him to be at C6 ASIA A spinal cord injury. The CT of his cervical spine revealed no fracture; however, an MRI revealed cord edema extending from C3 to C6 as well as posterior paraspinal signal abnormalities suggestive of ligamentous injury. RESULTS: The patient underwent a posterior cervical laminectomy and fusion from C3 to C7. Neurologically he regained 3/5 bilateral tricep function and 2/5 grip; otherwise, he remained at ASIA A spinal cord injury at 6 months. CONCLUSION: Our patient suffered a spinal cord injury likely due to existing cervical stenosis, and in addition to an overdose of sedating medications, he likely sat in flexed neck position for prolonged period of time with the inability to modify his position. This likely resulted in cervical spine vascular and/or neurological compromise producing an irreversible spinal cord injury. Spinal cord injury is a rare finding in patients presenting with drug overdose. The lack of physical exam findings suggestive of trauma may delay prompt diagnosis and treatment, and thus clinicians must have a high index of suspicion when evaluating patients in this setting.

Reversal of lifelong mutism after anterior cervical discectomy and fusion for myelopathy.

A 34-year-old man with a history of spina bifida occulta, fetal alcohol syndrome and mutism presented with an acute on chronic decline of unsteady gait and right arm and leg weakness over the period of a few months. The patient was non-verbal and communicated using hand gestures. MRI of the cervical spine showed severe stenosis at C4-5 with T2 signal abnormalities. Brain MRI demonstrated mild ventriculomegaly. The patient underwent an anterior cervical discectomy and fusion for severe cervical spine stenosis. Postoperatively the patient's myelopathic symptoms improved. He also became verbal and engaged in conversation. Ten months after surgery, the patient who had previously been non-verbal had developed a vocabulary of more than 50 words.