Patient Outcomes After Minimally Invasive Excision of Lumbar Synovial Cysts, With and Without a Spondylolisthesis, in an Ambulatory Care Center Setting.

Background: Lumbar synovial cysts are thought to signal facet joint degeneration and possible instability, leading some surgeons to routinely add a fusion to the decompressive procedure. These recommendations were formulated before the minimally invasive surgery (MIS) era. Here we describe our outcomes in surgical treatment of lumbar synovial cysts using MIS techniques.

Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up.

Background: Cervical total disc replacement (TDR) is an increasingly accepted procedure for the treatment of symptomatic cervical degenerative disc disease. Multiple Level I evidence clinical trials have established cervical TDR to be a safe and effective procedure in the short-term. The objective of this study is to provide a long-term assessment of TDR versus anterior discectomy and fusion for the treatment of one- and two-level disc disease.

The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes.

Introduction: Anterior cervical discectomy and fusion (ACDF) has been the gold standard for treating cervical degenerative disc disease (cDDD). The use of anterior plates in ACDF poses an increased risk of complications such as screw or plate dislodgement, soft tissue injury, esophagus perforation, and dysphagia. The ROI-C™ implant system consists of a zero-profile interbody fusion cage with self-locking plates designed for stand-alone fusion without external plates or screws.

Variability in Flexion Extension Radiographs of the Lumbar Spine: A Comparison of Uncontrolled and Controlled Bending.

Background: While low back pain is one of the most prevalent, if not the most prevalent reasons for visits to physicians, a majority of patients with low back pain cannot be given a definitive diagnosis. While there have been substantial advances in imaging technologies over the past 30 years, relatively little has changed in the methodologies for evaluating functionality of the lumbar spine. The current standard of care for function assessment of the lumbar spine focuses on uncontrolled patient directed motion which results in increased inter-patient variability.

Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis.

Background: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations.

Objective: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level.

Methods: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States.

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial.

Introduction: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression.

Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up.

OBJECTIVE Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7.

Measurement Performance of a Computer Assisted Vertebral Motion Analysis System.

Background: Segmental instability of the lumbar spine is a significant cost within the US health care system; however current thresholds for indication of radiographic instability are not well defined.

Purpose: To determine the performance measurements of sagittal lumbar intervertebral measurements using computerassisted measurements of the lumbar spine using motion sequences from a video-fluoroscopic technique.

Study Design: Sensitivity, specificity, predictive values, prevalence, and test-retest reliability evaluation of digitized manual versus computer-assisted measurements of the lumbar spine.

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.

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results.

Object: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.

Methods: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S.

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.

Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article.

Object: Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine.

Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial.

Study Design: Prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial.

Objective: To evaluate the safety and efficacy of Coflex interlaminar stabilization compared with posterior spinal fusion in the treatment of 1- and 2-level spinal stenosis and degenerative spondylolisthesis.

Summary Of Background Data: Long-term untoward sequelae of lumbar fusion for stenosis and degenerative spondylolisthesis have led to the search for motion-preserving, less-invasive alternatives.