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.

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.

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.

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.

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.

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.

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.

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.