Anterior and Lateral Lumbar Interbody Fusion With Supplemental Interspinous Process Fixation: Outcomes from a Multicenter, Prospective, Randomized, Controlled Study.

Background: Rigid interspinous process fixation (ISPF) has received consideration as an efficient, minimally disruptive technique in supporting lumbar interbody fusion. However, despite advantageous intraoperative utility, limited evidence exists characterizing midterm to long-term clinical outcomes with ISPF. The objective of this multicenter study was to prospectively assess patients receiving single-level anterior (ALIF) or lateral (LLIF) lumbar interbody fusion with adjunctive ISPF.

Systemic Hypothermia as Treatment for an Acute Cervical Spinal Cord Injury in a Professional Football Player: 9-Year Follow-Up.

The following report provides clinical follow-up on a National Football League player who sustained a complete cervical spinal cord injury (SCI) while tackling an opposing player in 2007. He received prompt medical and surgical care based on then-current recommendations, but was also treated with systemic hypothermia soon after his injury, which was controversial at the time. Since then, smaller randomized human studies have described the tolerable safety profile, efficacy, and potential benefits of this intervention in acute SCI in humans.

A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial.

Study Design: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial.

Objective: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1.

Summary Of Background Data: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series.

Systemic hypothermia for the treatment of acute cervical spinal cord injury in sports.

Spinal cord injury is a devastating condition that affects approximately 12,000 patients each year in the United States. Major causes for spinal cord injury include motor vehicle accidents, sports-related injuries, and direct trauma. Moderate hypothermia has gained attention as a potential therapy due to recent experimental and clinical studies and the use of modest systemic hypothermia (MSH) in high profile case of spinal cord injury in a National Football League (NFL) player.

Biomechanical analysis and review of lateral lumbar fusion constructs.

Study Design: Biomechanical study and the review of literature on lumbar interbody fusion constructs.

Objective: To demonstrate the comparative stabilizing effects of lateral interbody fusion with various supplemental internal fixation options.

Summary Of Background Data: Lumbar interbody fusion procedures are regularly performed using anterior, posterior, and more recently, lateral approaches.

The use of systemic hypothermia for the treatment of an acute cervical spinal cord injury in a professional football player.

Study Design: Case Report.

Objective: We will describe the injury and clinical course of an NFL Football player who sustained a complete spinal cord injury and was treated with conventional care in addition to modest systemic hypothermia.

Summary Of Background Data: Systemically induced moderate hypothermia is a potentially neuroprotective intervention in acute spinal cord injury.

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.

Porous coated motion cervical disc replacement: a biomechanical, histomorphometric, and biologic wear analysis in a caprine model.

Study Design: The biomechanical, histopathologic, and histomorphometric characteristics of cervical disc replacement were assessed in a caprine animal model.

Objective: To investigate the biomechanical, porous ingrowth, and histopathologic characteristics of the Porous Coated Motion (PCM) Cervical Disc replacement (Cervitech, Inc., Rockaway, NJ).

Anterior cervical discectomy and fusion with implantable titanium cage: initial impressions, patient outcomes and comparison to fusion with allograft.

Background Context: The use of metal cage prosthetic devices in anterior cervical discectomy with fusion (ACDF) has increased rapidly. One of these devices is the titanium Rabea cage (Signus, Alzenau, Germany) [correction]. There are no peer-reviewed objective reports on the use of these cages in cervical discectomy.