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.

Nitrilase mediated mild hydrolysis of a carbon-14 nitrile for the radiosynthesis of 4-(7-hydroxycarbamoyl-[1- C-heptanoyl]-oxy)-benzoic acid methyl ester, [ C]-SHP-141: A novel class I/II histone deacetylase (HDAC) inhibitor.

A strategy has been developed for the carbon-14 radiosynthesis of [ C]-SHP-141, a 4-(7-hydroxycarbamoyl-heptanoyloxy)-benzoic acid methyl ester derivative containing a terminal hydroxamic acid. The synthesis involved four radiochemical transformations. The key step in the radiosynthesis was the conversion of the 7-[ C]-cyano-heptanoic acid benzyloxyamide [ C]-4 directly into the carboxylic acid derivative, 7-benzyloxycarbamoyl-[ C]-heptanoic acid [ C]-8 using nitrilase-113 biocatalyst.

Cervical fusion for treatment of degenerative conditions: development of appropriate use criteria.

Background Context: High quality evidence is difficult to generate, leaving substantial knowledge gaps in the treatment of spinal conditions. Appropriate use criteria (AUC) are a means of determining appropriate recommendations when high quality evidence is lacking.

Purpose: Define appropriate use criteria (AUC) of cervical fusion for treatment of degenerative conditions of the cervical spine.

Management of degenerative spondylolisthesis: development of appropriate use criteria.

Background Context: Outcomes of treatment in care of patients with spinal disorders are directly related to patient selection and treatment indications. However, for many disorders, there is absence of consensus for precise indications. With the increasing emphasis on quality and value in spine care, it is essential that treatment recommendations and decisions are optimized.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain.

Background Context: The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016.

Purpose: The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain.

Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population.

Lumbar disc herniation (LDH) is one of the most common spinal pathologies and can be associated with debilitating pain and neurological dysfunction. Discectomy is the primary surgical intervention for LDH and is typically successful. Yet, some patients experience recurrent LDH (RLDH) after discectomy, which is associated with worse clinical outcomes and greater socioeconomic burden.

Synthesis of carbon-14-labelled peptides.

Carbon-14 ( C)-labelled active pharmaceutical ingredients (APIs) and investigational medicinal products (IMPs) are required for phase 0/I to phase III mass balance and micro-dosing clinical trials. In some cases, this may involve the synthesis of C-labelled peptides, and the analysis can be performed by accelerated mass spectrometry (AMS). The C-peptide is typically prepared by the solid-phase peptide synthesis (SPPS) approach using custom-made glassware for the key coupling steps.

The Global Spine Care Initiative: care pathway for people with spine-related concerns.

Purpose: The purpose of this report is to describe the development of an evidence-based care pathway that can be implemented globally.

Methods: The Global Spine Care Initiative (GSCI) care pathway development team extracted interventions recommended for the management of spinal disorders from six GSCI articles that synthesized the available evidence from guidelines and relevant literature. Sixty-eight international and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate.

The Global Spine Care Initiative: World Spine Care executive summary on reducing spine-related disability in low- and middle-income communities.

Purpose: Spinal disorders, including back and neck pain, are major causes of disability, economic hardship, and morbidity, especially in underserved communities and low- and middle-income countries. Currently, there is no model of care to address this issue. This paper provides an overview of the papers from the Global Spine Care Initiative (GSCI), which was convened to develop an evidence-based, practical, and sustainable, spinal healthcare model for communities around the world with various levels of resources.

The Global Spine Care Initiative: methodology, contributors, and disclosures.

Purpose: The purpose of this report is to describe the Global Spine Care Initiative (GSCI) contributors, disclosures, and methods for reporting transparency on the development of the recommendations.

Methods: World Spine Care convened the GSCI to develop an evidence-based, practical, and sustainable healthcare model for spinal care. The initiative aims to improve the management, prevention, and public health for spine-related disorders worldwide; thus, global representation was essential.

The Global Spine Care Initiative: classification system for spine-related concerns.

Purpose: The purpose of this report is to describe the development of a classification system that would apply to anyone with a spine-related concern and that can be used in an evidence-based spine care pathway.

Methods: Existing classification systems for spinal disorders were assembled. A seed document was developed through round-table discussions followed by a modified Delphi process.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators as an adjunct for lumbar fusion.

The relationship between the formation of a solid arthrodesis and electrical and electromagnetic energy is well established; most of the information on the topic, however, pertains to the healing of long bone fractures. The use of both invasive and noninvasive means to supply this energy and supplement spinal fusions has been investigated. Three forms of electrical stimulation are routinely used: direct current stimulation (DCS), pulsed electromagnetic field stimulation (PEMFS), and capacitive coupled electrical stimulation (CCES).

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion.

In an attempt to enhance the potential to achieve a solid arthrodesis and avoid the morbidity of harvesting autologous iliac crest bone (AICB) for a lumbar fusion, numerous alternatives have been investigated. The use of these fusion adjuncts has become routine despite a lack of convincing evidence demonstrating a benefit to justify added costs or potential harm. Potential alternatives to AICB include locally harvested autograft, calcium-phosphate salts, demineralized bone matrix (DBM), and the family of bone morphogenetic proteins (BMPs).

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 15: electrophysiological monitoring and lumbar fusion.

Intraoperative monitoring (IOM) is commonly used during lumbar fusion surgery for the prevention of nerve root injury. Justification for its use stems from the belief that IOM can prevent nerve root injury during the placement of pedicle screws. A thorough literature review was conducted to determine if the use of IOM could prevent nerve root injury during the placement of instrumentation in lumbar or lumbosacral fusion.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 14: brace therapy as an adjunct to or substitute for lumbar fusion.

The utilization of orthotic devices for lumbar degenerative disease has been justified from both a prognostic and therapeutic perspective. As a prognostic tool, bracing is applied prior to surgery to determine if immobilization of the spine leads to symptomatic relief and thus justify the performance of a fusion. Since bracing does not eliminate motion, the validity of this assumption is questionable.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion.

The medical literature continues to fail to support the use of lumbar epidural injections for long-term relief of chronic back pain without radiculopathy. There is limited support for the use of lumbar epidural injections for shortterm relief in selected patients with chronic back pain. Lumbar intraarticular facet injections are not recommended for the treatment of chronic lower-back pain.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 12: pedicle screw fixation as an adjunct to posterolateral fusion.

The utilization of pedicle screw fixation as an adjunct to posterolateral lumbar fusion (PLF) has become routine, but demonstration of a definitive benefit remains problematic. The medical evidence indicates that the addition of pedicle screw fixation to PLF increases fusion rates when assessed with dynamic radiographs. More recent evidence, since publication of the 2005 Lumbar Fusion Guidelines, suggests a stronger association between radiographic fusion and clinical outcome, although, even now, no clear correlation has been demonstrated.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 11: interbody techniques for lumbar fusion.

Interbody fusion techniques have been promoted as an adjunct to lumbar fusion procedures in an effort to enhance fusion rates and potentially improve clinical outcome. The medical evidence continues to suggest that interbody techniques are associated with higher fusion rates compared with posterolateral lumbar fusion (PLF) in patients with degenerative spondylolisthesis who demonstrate preoperative instability. There is no conclusive evidence demonstrating improved clinical or radiographic outcomes based on the different interbody fusion techniques.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis.

Lumbar stenosis is one of the more common radiographic manifestations of the aging process, leading to narrowing of the spinal canal and foramen. When stenosis is clinically relevant, patients often describe activity-related low-back or lower-extremity pain, known as neurogenic claudication. For those patients who do not improve with conservative care, surgery is considered an appropriate treatment alternative.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis.

Patients presenting with stenosis associated with a spondylolisthesis will often describe signs and symptoms consistent with neurogenic claudication, radiculopathy, and/or low-back pain. The primary objective of surgery, when deemed appropriate, is to decompress the neural elements. As a result of the decompression, the inherent instability associated with the spondylolisthesis may progress and lead to further misalignment that results in pain or recurrence of neurological complaints.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy.

Patients suffering from a lumbar herniated disc will typically present with signs and symptoms consistent with radiculopathy. They may also have low-back pain, however, and the source of this pain is less certain, as it may be from the degenerative process that led to the herniation. The surgical alternative of choice remains a lumbar discectomy, but fusions have been performed for both primary and recurrent disc herniations.