Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial.

Study Design: The current study of 251 consecutive 1-level anterior cervical reconstructions was undertaken to compare the incidence of dysphagia between cervical disk replacement and conventional anterior cervical fusion and instrumentation.

Objectives: This is a report of 251 patients from 5 investigational centers in the Food and drug Administration's prospective, randomized porous-coated motion (PCM) trial using a validated dysphagia outcomes instrument. The dysphagia data for both PCM and anterior cervical diskectomy and fusion (ACDF) patients were reviewed from 5 centers to (1) compare the severity of dysphagia, (2) compare the postoperative incidence of dysphagia, and (3) to compare the resolution of perioperative dysphagia.

Cervical disc replacement in patients with and without previous adjacent level fusion surgery: a prospective study.

Study Design: Prospective 6-center study. OBJECTIVE.: To evaluate outcomes of cervical disc replacement performed adjacent to a prior cervical fusion.

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year 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.

Effect of previous surgery on clinical outcome following 1-level lumbar arthroplasty.

Object: A secondary lumbar surgery at a previously surgically treated level is believed to result in minimal clinical improvement. The clinical results of the CHARITE Investigational Device Exemption (IDE) study were analyzed to assess the effect of previous surgery on clinical outcomes following either total disc replacement with the CHARITE device or anterior lumbar interbody fusion with a BAK cage and iliac crest autograft.

Methods: Patients with prior microdiscectomy, laminectomy, or minimal medial facetectomy were not excluded from enrollment in the CHARITE IDE study.

Patient selection for lumbar arthroplasty and arthrodesis: the effect of revision surgery in a controlled, multicenter, randomized study.

Object: Patient selection is perhaps the most important factor in successful lumbar surgery. In this study, the authors analyzed the clinical outcomes of patients enrolled in the CHARITE investigational device exemption (IDE) trial who underwent revision surgery after primary total disc replacement with CHARITE or an anterior lumbar interbody fusion (ALIF) with placement of a BAK cage and iliac crest autograft. This revision surgery was either a supplemental posterior lumbar fixation or a 360 degrees fusion.

Distribution of in vivo and in vitro range of motion following 1-level arthroplasty with the CHARITE artificial disc compared with fusion.

Object: One of the goals of lumbar arthroplasty is to restore and maintain range of motion (ROM) and to protect adjacent levels from abnormal motion, which may be a factor in transition syndrome following arthrodesis. In this study, in vitro ROM results were compared with in vivo, 2-year postoperative radiographic ROM evaluations.

Methods: Radiographs of patients enrolled in the CHARITE investigational device exemption study were analyzed at baseline and at 2 years postoperatively.

An economic model of one-level lumbar arthroplasty versus fusion.

Background Context: Degenerative disc disease (DDD) is a cause of low back pain commonly requiring surgical intervention. The option of lumbar total disc replacement (TDR) represents an advance in the surgical treatment of DDD. However, new treatments, particularly those that include the use of new implants, may lead to increased costs to both hospitals and payers.

Revision and explantation strategies involving the CHARITE lumbar artificial disc replacement.

Study Design: A large case series of anterior revision surgery in patients who had complications following lumbar total disc replacement with the CHARITE artificial disc.

Objectives: To analyze and discuss the etiology of implant-related complications and to present a strategy that can be applied to lumbar intervertebral disc prostheses in cases where anterior revision surgery is necessary.

Summary Of Background Data: This report represents the largest single-site, consecutive case series reported in the literature of anterior revision surgery following lumbar disc arthroplasty.

Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc.

Background: Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion.

Methods: In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages).

The first 18 months following food and drug administration approval of lumbar total disc replacement in the United States: reported adverse events outside an investigational device exemption study environment.

Background: Introduction of a new surgical technology may result in higher rates of adverse events compared with rates reported in the study performed to gain regulatory approval. The purpose of our study was to describe the incidence of reported adverse events during the first 18 months following US Food and Drug Administration (FDA) approval of the first lumbar arthroplasty device available in the United States and to discern data trends.

Methods: Reports of adverse events submitted to the FDA in patients receiving the Charité artificial disc were reviewed and pooled by similarity.

Access strategies for revision or explantation of the Charité lumbar artificial disc replacement.

Background: Several lumbar disc prostheses are being developed with the goal of preserving mobility in patients with degenerative disc disease. The disadvantage of lumbar artificial disc replacement (ADR) compared with anterior interbody fusion (ALIF) is the increased potential for displacement or component failure. Revision or removal of the device is complicated by adherence of the aorta, iliac vessels, and the ureter to the operative site.

Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charité Artificial Disc.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial.

Objectives: To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study.

Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc.

Study Design: A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial.

Objectives: To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study.

Summary Of Background Data: This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multicenter trial.

A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated, investigational device exemption clinical trial.

Objectives: To compare the safety and effectiveness of lumbar total disc replacement (TDR) with the CHARITE artificial disc (DePuy Spine, Raynham, MA) to anterior lumbar interbody fusion for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. In addition, to evaluate the radiographic outcomes of lumbar artificial disc replacement at either L4-L5 or L5-S1 with the CHARITE artificial disc as compared to anterior lumbar interbody fusion with cylindrical cages and iliac crest bone graft; and to determine if a correlation exists between clinical outcomes and surgical accuracy of TDR placement within the disc space.

A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.

Objectives: The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment.

Summary Of Background Data: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes.

Clinical results of charité lumbar total disc replacement.

To preserve segmental lumbar motion and to prevent adjacent segment disease, there has been a growing enthusiasm for the use of intervertebral disc prosthesis as an alternative to segmental lumbar fusion. To date, more than 100-disc prostheses have been designed, but only 10 prostheses have been approved and implanted in humans. The Charité Artificial Disc has had the longest clinical follow-up with more than 5000 implantations in over 30 countries and reported > 10-year satisfactory results.

The changing role for neurosurgeons and the treatment of spinal deformity.

Spinal deformity has classically and historically been studied by those in the discipline of orthopedic surgery. This may be attributable to the orthopedic interventionalists' experience with osseous fixation for long-bone and other skeletal fractures. Neurosurgeons have maintained a long-standing interest in complex cervical spinal disorders, and their interest in the larger field of complex spinal deformity has been expanding.

Sagittal alignment and the Bryan cervical artificial disc.

Object: The authors evaluated cervical spine radiographs to determine sagittal alignment in patients who underwent one- or two-level arthroplasty with the Bryan cervical artificial disc prosthesis.

Methods: The curvature of the surgically treated spinal segments and the overall curvature of the cervical spine were evaluated in 13 patients who underwent 16 cervical arthroplasty device placements. Preoperative and postoperative lateral radiographs were reviewed and compared using standardized techniques for measuring spinal curvature.

Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004.

Object: Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process.

Endoscopic lateral transpsoas approach to the lumbar spine.

Study Design: A description of a novel surgical approach to the lumbar spine and a prospective evaluation of the early surgical outcomes.

Objectives: Describe the early postoperative results and the operative technique of a new, minimally invasive transpsoas approach for anterior fusion of the lumbar spine that minimizes the risk to large vessels and other critical structures.

Summary Of Background Data: Standard anterior endoscopic approaches to the lumbar spine require mobilization of the great vessels and sympathetic plexus.

Video-assisted thoracoscopic surgery for thoracic disc disease: Classification and outcome study of 100 consecutive cases with a 2-year minimum follow-up period.

Study Design: Prospectively collected data from regular clinical follow-up evaluations were tabulated, analyzed, reviewed using a patient self-reported questionnaire.

Objective: To develop a classification system and present the long-term functional outcome of video-assisted thorascopic surgery for refractory thoracic disc disease.

Summary Of Background Data: Recent studies have found an 11.

Thoracoscopic microdiscectomy.

The thorascopic approach for the microsurgical removal of herniated thoracic discs is described, and perioperative management is also discussed. The microsurgical techniques used for decompression of the spinal canal in the thoracic spine are presented in detail. The diagnostic imaging, surgical positioning, approach, port placement, localization of the thoracic level, exposure of the surgical field, excision of the rib head, exposure with removal of the herniated disc, and postoperative management are outlined.