Introduction: The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures.
Objective: The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology.
Objective Lumbar fusion performed through lateral approaches is becoming more common. The interbody devices are generally supported by supplemental posterior fixation implanted through a posterior approach, potentially requiring a second incision and intraoperative repositioning of the patient. A minimally invasive lateral interspinous fixation device may eliminate the need for intraoperative repositioning and avoid disruption of the supraspinous ligament.
View Article and Find Full Text PDFStudy Design: This is a retrospective analysis of data that were collected prospectively from 2 concurrent FDA IDE lumbar arthroplasty clinical trials performed at a single center.
Objectives: The purpose of this study was to determine if factors differentiating those patients with the best and worst clinical outcomes from total disc arthroplasty (TDR) could be identified.
Summary Of Background Data: Overall the results of TDR have been favorable, including recent results from 2 FDA IDE trials conducted in the United States.
Background Context: A recent study involving interbody fusion patients found that preoperative work status was significantly related to clinical outcome. In another study comparing the best and worst outcomes of total disc replacement, among a battery of variables analyzed, the only one that differentiated the best and worst outcome groups was the length of time off work before total disc replacement.
Purpose: The purpose of this study was to determine if there was a relationship between the length of time off work and treatment outcome at 24-month follow-up.
Background Context: The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date.
Purpose: The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment.