Five-Year Follow-Up of a Prospective, Randomized Trial Comparing Two Lumbar Total Disc Replacements.

Study Design: This was a prospective, randomized, controlled, multicenter study.

Objective: The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant.

Summary Of Background Data: Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures.

Associations Between Pre-Implant Psychosocial Factors and Spinal Cord Stimulation Outcome: Evaluation Using the MMPI-2-RF.

Spinal cord stimulation (SCS) has variable effectiveness in controlling chronic pain. Previous research has demonstrated that psychosocial factors are associated with diminished results of SCS. The objective of this investigation is to examine associations between pre-implant psychological functioning as measured by the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) and SCS outcomes.

Development of a novel radiographic measure of lumbar instability and validation using the facet fluid sign.

Background: Lumbar spinal instability is frequently referenced in clinical practice and the scientific literature despite the lack of a standard definition or validated radiographic test. The Quantitative Stability Index (QSI) is being developed as a novel objective test for sagittal plane lumbar instability. The QSI is calculated using lumbar flexion-extension radiographs.

Two novel high performing composite PMMA-CaP cements for vertebroplasty: An ex vivo animal study.

There is a growing body of the literature on new cement formulations that address the shortcomings of PMMA bone cements approved for use in vertebroplasty (VP) and balloon kyphoplasty (BKP). The present study is a contribution to these efforts by further characterization of two pre-mixed CaP filler-reinforced PMMA bone cements intended for VP; namely, PMMA-HA and PMMA-brushite cements. Each of these cements showed acceptable levels of various properties determined in porcine vertebral bodies.

Spinal Myeloid Sarcoma "Chloroma" Presenting as Cervical Radiculopathy: Case Report.

Study Design Case report. Objective Myeloid sarcoma (also known as chloroma) is a rare, extramedullary tumor composed of immature granulocytic cells. It may occur early in the course of acute or chronic leukemia or myeloproliferative disorders.

Posterolateral Lumbar Arthrodesis With and Without Interbody Arthrodesis for L4-L5 Degenerative Spondylolisthesis: A Comparative Value Analysis.

Study Design: Independent retrospective review of prospectively collected data, comparative cohort study.

Objective: The objective of this study was to compare the clinical, radiographical, and cost/value of the addition of an interbody arthrodesis (IBA) to a posterolateral arthrodesis (PLA) in the surgical treatment of L4-L5 degenerative spondylolisthesis (DS). The authors hypothesized that the addition of IBA to PLA would produce added value while incurring minimal additional costs.

The Incidence of Lumbar Discectomy after Epidural Steroid Injections or Selective Nerve Root Blocks.

Background: The purpose of this study was to determine the use of Central Epidural Steroid Injections (ESI) and Selective Nerve Root Blocks (SNRB) along with the crossover rate to lumbar discectomy in patients with a lumbar disc herniation using retrospective records database search. Butterman et al found a crossover rate for patients with symptomatic disc herniations treated with ESI of 54% (27/50), while Riew similarly found a 53% (29/55) crossover patients receiving SNRB.

Methods: The database was searched in a sequential Boolean style for patients with the diagnosis of a lumbar disc herniation (Displaced Lumbar Disc - 722.

Radiologic and clinical characteristics of vertebral fractures in multiple myeloma.

Background Context: Nearly 80% of patients with newly diagnosed multiple myeloma (MM) have bony lesions on magnetic resonance imaging (MRI). These lesions may progress to debilitating vertebral fractures. No studies have quantitatively characterized these fractures or identified predictors of fracture burden and severity.

Costs of cervical disc replacement versus anterior cervical discectomy and fusion for treatment of single-level cervical disc disease: an analysis of the Blue Health Intelligence database for acute and long-term costs and complications.

Study Design: Retrospective review of prospectively collective administrative data.

Objective: The purpose of this study was to determine the reoperation rates, adverse event rate, as well as the direct and follow-on costs of cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF) in a "real-world" population of patients with single-level symptomatic cervical disc disease.

Summary Of Background Data: Until very recently, there was a paucity of human clinical data to demonstrate that CDA lowers the rate of adjacent segment disease over ACDF.

A proposed set of metrics for standardized outcome reporting in the management of low back pain.

Background And Purpose: Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes.

Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial.

Study Design: A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine.

Objective: To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up.

Summary Of Background Data: Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months.

ISASS Policy Statement - Lumbar Artificial Disc.

Purpose: The primary goal of this Policy Statement is to educate patients, physicians, medical providers, reviewers, adjustors, case managers, insurers, and all others involved or affected by insurance coverage decisions regarding lumbar disc replacement surgery.

Procedures: This Policy Statement was developed by a panel of physicians selected by the Board of Directors of ISASS for their expertise and experience with lumbar TDR. The panel's recommendation was entirely based on the best evidence-based scientific research available regarding the safety and effectiveness of lumbar TDR.

Lumbar dorsal root Ganglia location: an anatomic and MRI assessment.

Background: The dorsal root ganglion (DRG) is a key structure in the mechanism of symptomatic radicular pain, weakness and change in sensation. DRG localization can assist in the decision making process of which areas require decompression, and type of procedure that should be performed to treat radicular symptoms. In this study we determine dimensions of lumbar foramina, DRG and its relationship to the neuroforamina through anatomic and magnetic resonance imaging (MRI) evaluation Agreement between MRI and anatomic assessment of DRG location will be determined.

Robotic assisted surgeries for the treatment of spine tumors.

Background: Surgery plays an important role in the treatment of patients with metastatic or primary spine tumors. In recent years, various new techniques, such as robotic assisted spine surgery have been developed which has shown some promising results by improving the accuracy of spinal instrumentation and reducing potential complications. The purpose of this study was to evaluate our early experience using robotic guidance in the treatment of spinal tumors.

Indications for lumbar total disc replacement: selecting the right patient with the right indication for the right total disc.

Summary Of Background Data: As with any surgery, care should be taken to determine patient selection criteria for lumbar TDR based on safety and optimizing outcome. These goals may initially be addressed by analyzing biomechanical implant function and early clinical experience, ongoing evaluation is needed to refine indications.

Objective: The purpose of this work was to synthesize information published on general indications for lumbar TDR.

Thoracic and lumbar vertebrae morphology in Lenke type 1 female adolescent idiopathic scoliosis patients.

Background: Pedicle screws are widely used in adolescent idiopathic scoliosis (AIS) surgeries. Pedicle screw malposition may lead to serious vascular and neurologic complications. Knowledge of the morphometric anatomy of the thoracic and lumbar vertebrae is essential for the surgeon while implanting pedicle screws.

Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine.

Background: Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration.

Clinical outcomes of a polyaxial interspinous fusion system.

Background: Early interspinous process fixation constructs utilize rigid fixation plates with immobile spikes which increase the difficulty of device implantation when anatomic variations are encountered. Second generation systems have been designed with polyaxial properties with the goal of accommodating natural osseous anatomic variations to achieve optimal implant placement and fixation integrity. The purpose of this study was to evaluate clinical outcomes in patients treated with this device to supplement the biomechanical data from previous studies.

Healthcare Engineering Defined: A White Paper.

Engineering has been playing an important role in serving and advancing healthcare. The term "Healthcare Engineering" has been used by professional societies, universities, scientific authors, and the healthcare industry for decades. However, the definition of "Healthcare Engineering" remains ambiguous.

Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial.

Study Design: Prospective, multicenter, randomized, controlled, investigational device exemption noninferiority trial.

Objective: To determine 2-year outcomes in patients with intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis (LSS) who were treated with the Superion interspinous process spacer.

Summary Of Background Data: Interspinous spacers are a less-invasive treatment alternative compared with surgical decompression for patients with LSS unresponsive to conservative care.

The Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF): incremental validity in predicting early postoperative outcomes in spine surgery candidates.

A substantial proportion of individuals who undergo surgical procedures to relieve spine pain continue to report significant pain and dysfunction after recovery. Psychopathology and patient expectations have been linked to poor results, leading to an increasing reliance on presurgical psychological screening (PPS) as part of the surgical diagnostic process. The original Minnesota Multiphasic Personality Inventory (MMPI; Hathaway & McKinley, 1943) and the MMPI-2 (Butcher, Graham, Ben-Porath, Tellegen, & Dahlstrom, 2001) were among the measures most commonly used in PPS evaluations and research.

Lower extremity fatigue, sex, and landing performance in a population with recurrent low back pain.

Context: Low back pain and lower extremity injuries affect athletes of all ages. Previous authors have linked a history of low back pain with lower extremity injuries. Fatigue is a risk factor for lower extremity injuries, some of which are known to affect female athletes more often than their male counterparts.

The fate of prospective spine studies registered on www.ClinicalTrials.gov.

Background Context: There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov.

Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up.

Study Design: This was a prospective, randomized, controlled multicenter trial.

Objective: The purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF).

Summary Of Background Data: ACDF has been the traditional treatment for symptomatic disk degeneration.