Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results.

Background: This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes.

Methods: This was a prospective, multicenter, randomized, controlled investigational device exemption study.

Long-Term Clinical Outcomes With the Activ-L Lumbar Arthroplasty System.

Background: Low back pain (LBP) due to degenerative disc disease (DDD) is the most common occupational disorder worldwide. Lumbar total disc replacement (LTDR) has provided an alternative to rigid fusion to relieve pain with less motion restriction. We present clinical results with long-term follow-up from a single-center, single-surgeon series of patients treated with the Activ-L artificial disc.

Lumbar Arthroplasty: Past, Present, and Future.

Lumbar degenerative disc disease is a pathologic process that affects a large portion of our aging population. In the recent past, surgical treatment has involved fusion procedures. However, lumbar disc arthroplasty and replacement provides an alternative for carefully selected patients.

Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease.

Study Design: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.

Objective: The aim of this study was to compare the 5-year safety and effectiveness of the activL Artificial Disc with Control Total Disc Replacement (TDR) systems (ProDisc-L or Charité) in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD).

Summary Of Background Data: The activL Artificial Disc received Food and Drug Administration approval in 2015 based on 2-year follow-up data.

Challenges and Solutions for Lumbar Total Disc Replacement Implantation.

: Long-term data are now available to support the safety and efficacy of lumbar total disc replacement (TDR). Five-year randomized and controlled trials, meta-analyses, and observational studies support a similar or lower risk of complications with lumbar TDR compared with fusion. The panel concluded that published data on commercially available lumbar TDR devices demonstrate minimal concerns with late-onset complications, and that the risk of adjacent segment degeneration and reoperations can be reduced with lumbar TDR versus fusion.

Foreword: Proceedings From the First Annual Lumbar Total Disc Replacement Summit.

: This publication focuses on proceedings from the First Annual Lumbar Total Disc Replacement Summit, held October 25, 2016 in Boston, MA. The Summit brought together 17 thought leading surgeons who employed a modified-Delphi method to determine where consensus existed pertaining to the utilization of lumbar total disc replacement as a standard of care for a subpopulation of patients suffering from degenerative disc disease.

The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain.

Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration - the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006.

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.

Failure of posterior titanium atlantoaxial cable fixation.

Background Context: The operative treatment of rotatory atlantoaxial instability remains controversial. The use of cable fixation has largely replaced the use of wire for interlaminar fixation. Although cable fixation offers biomechanical advantages over wire fixation, it is still at risk of fatigue failure.