The 5-year cost-effectiveness of anterior cervical discectomy and fusion and cervical disc replacement: a Markov analysis.

Study Design: A Markov state-transition model was developed to evaluate the cost-effectiveness of anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) at 5 years.

Objective: To determine the cost-effectiveness of ACDF and CDR at 5 years.

Summary Of Background Data: ACDF and CDR are surgical options for the treatment of an acute cervical disc herniation with associated myelopathy/radiculopathy.

Characterization of a new composite PMMA-HA/Brushite bone cement for spinal augmentation.

Calcium phosphate fillers have been shown to increase cement osteoconductivity, but have caused drawbacks in cement properties. Hydroxyapatite and Brushite were introduced in an acrylic two-solution cement at varying concentrations. Novel composite bone cements were developed and characterized using rheology, injectability, and mechanical tests.

Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up.

Study Design: This was a prospective, randomized, controlled multicenter study with 24-month follow-up.

Objective: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale.

Summary Of Background Data: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion.

Retro-odontoid calcium pyrophosphate dehydrate deposition: surgical management and review of the literature.

Study Design Case report and review of the literature. Objective A retro-odontoid mass is a rare cause of cervical compression and myelopathy. The differential diagnosis includes the following: metastatic disease, primary tumor, collagen disorder, or inflammatory disease.

What is the learning curve for robotic-assisted pedicle screw placement in spine surgery?

Background: Some early studies with robotic-assisted pedicle screw implantation have suggested these systems increase accuracy of screw placement. However, the relationship between the success rate of screw placement and the learning curve of this new technique has not been evaluated.

Questions/purposes: We determined whether, as a function of surgeon experience, (1) the success rate of robotic-assisted pedicle screw placement improved, (2) the frequency of conversion from robotic to manual screw placement decreased, and (3) the frequency of malpositioned screws decreased.

Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients.

Introduction: The ultrasonic BoneScalpel is a tissue-specific device that allows the surgeon to make precise osteotomies while protecting collateral or adjacent soft tissue structures. The device is comprised of a blunt ultrasonic blade that oscillates at over 22,500 cycles/s with an imperceptible microscopic amplitude. The recurring impacts pulverize the noncompliant crystalline structure resulting in a precise cut.

Reoperations in cervical total disc replacement compared with anterior cervical fusion: results compiled from multiple prospective food and drug administration investigational device exemption trials conducted at a single site.

Study Design: This study is based on a post hoc analysis of data collected from multiple prospective, randomized studies conducted at the same site.

Objective: The purpose of this study was to compare the reoperation rates in patients with cervical total disc replacement (TDR) versus patients with anterior cervical fusion (ACF).

Summary Of Background Data: One important evaluation of any new technology is the safety, including the need for future surgery.

Does 360° lumbar spinal fusion improve long-term clinical outcomes after failure of conservative treatment in patients with functionally disabling single-level degenerative lumbar disc disease? Results of 5-year follow-up in 75 postoperative patients.

Background: Surgical treatment of patients with mechanical degenerative disc disease has been controversial, but improvements in clinical outcomes have been shown in properly selected patients with disease-specific diagnoses, with fusion arguably now becoming the "gold standard" for surgical management of these patients. No published study thus far has been designed for prospective enrollment of patients with specific inclusion/exclusion criteria in whom at least 6 months of conservative therapy has failed and who are then offered a standardized surgical procedure and are followed up for 5 years.

Methods: The study group was composed of the patients in the prospective, randomized Food and Drug Administration Investigational Device Exemption trial comparing ProDisc-L (Synthes Spine, West Chester, Pennsylvania) with 360° fusion for the treatment of single-level symptomatic disc degeneration.

Five-year reoperation rates, cervical total disc replacement versus fusion, results of a prospective randomized clinical trial.

Study Design: Prospective randomized clinical trial.

Objective: Determine the reasons for, and rates of, secondary surgical intervention up to 5 years at both the index and adjacent levels in patients treated with cervical total disc replacement (TDR) or anterior cervical discectomy and fusion (ACDF). Patients undergoing TDR received ProDisc-C.

Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion.

Object: The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD).

Methods: Two hundred thirty-six patients with single-level lumbar DDD were enrolled and randomly assigned to 2 treatment groups: 161 patients in the TDR group were treated using the ProDisc-L (Synthes Spine, Inc.), and 75 patients were treated with circumferential fusion.

Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease.

Object: The purpose of this study was to evaluate the long-term safety and effectiveness of the ProDisc-L total disc replacement (TDR) as part of an FDA-mandated postmarket approval study. This report summarizes the clinical findings after 5 years of follow-up.

Methods: Two hundred thirty-six patients were treated and followed up for 5 years; 161 TDRs and 75 fusions had been performed in these patients.

ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study.

Study Design: Randomized controlled trial.

Objective: Analyze the clinical outcomes at 5 years comparing cervical total disc replacement (TDR) with ProDisc-C (Synthes Spine USA Products; LLC, West Chester, PA) with anterior cervical discectomy and fusion (ACDF).

Summary Of Background Data: Previous reports of 2- and 4-year results have shown that ProDisc-C, a TDR for surgical treatment of patients experiencing single-level symptomatic cervical disc disease between C3 and C7, is safe and effective.

Psychological risk factors for poor outcome of spine surgery and spinal cord stimulator implant: a review of the literature and their assessment with the MMPI-2-RF.

Back pain is experienced by up to of 85% of the United States population. Most often it resolves with minimal to no medical treatment. For those whose pain endures, worsens, or becomes protracted, conservative care is typically first attempted.

Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients.

Introduction: Surgeons' interest in image and/or robotic guidance for spinal implant placement is increasing. This technology is continually improving and may be particularly useful in patients with challenging anatomy. Only through careful clinical evaluation can its successful applications, limitations, and areas for improvement be defined.

Proximal instrumented vertebral body chance fracture after pedicle screw instrumentation in a thoracic kyphosis patient with osteoporosis.

Study Design: We present a case of proximal vertebral body chance fracture after pedicle screw instrumentation and fusion in a 67-year-old woman with osteoporosis and thoracic kyphosis.

Objective: To report the rare and unique complication of proximal vertebral body chance fracture after pedicle screw instrumentation and fusion in a kyphosis patient.

Summary Of Background Data: Pedicle screw instrumentation has been associated with complications not limited to neurological or vascular injury, loss of curve correction, intraoperative pedicle fracture or loosening, dural laceration, deep infection, and pseudarthrosis.

L5 radiculopathy caused by L5 nerve root entrapment by an L5-S1 anterior osteophyte.

Background: L5 radiculopathy is a common problem that has several causes. Entrapment of the L5 nerve root by anterior osteophytes at the L5-S1 junction is rarely reported. Posterior decompression of the L5 nerve root is commonly performed, but anterior decompression of the L5 nerve root is not a frequently performed procedure.

Analysis of adjacent segment reoperation after lumbar total disc replacement.

Background: Fusion has long been used for treating chronic back pain unresponsive to nonoperative care. However, potential development of adjacent segment degeneration resulting in reoperation is a concern. Total disc replacement (TDR) has been proposed as a method for addressing back pain and preventing or reducing adjacent segment degeneration.

Minimally invasive trans-sacral approach to L5-S1 interbody fusion: Preliminary results from 1 center and review of the literature.

Background: Lumbar interbody fusion has long been used for the treatment of painful degenerative spinal conditions. The anterior approach is not feasible in some patients, and the posterior approach is associated with a risk of neural complications and possibly muscle injury. A trans-sacral technique was developed that allows access to the L5-S1 disc space.

Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration-regulated feasibility study with 24-month follow-up.

Background: Anterior cervical fusion, an established procedure to treat cervical radiculopathy, sacrifices the natural function of the disc, while placing increased stresses on adjacent spinal levels. In contrast, the cervical total disc replacement (cTDR) maintains motion and decreases adjacent-level stresses. The purpose of this study was to investigate the safety and effectiveness of a next-generation cTDR device in patients with symptomatic cervical radiculopathy.

Assessment of pedicle screw placement accuracy, procedure time, and radiation exposure using a miniature robotic guidance system.

Study Design: Controlled, cadaveric implantation trial.

Objective: To evaluate the effect of a robotic guidance system on screw placement accuracy, amount of radiation exposure, and length of procedure time during percutaneous pedicle screw implantation.

Summary Of Background Data: Pedicle screws are associated with low complication rates, and several computer-assisted image guidance systems exist that facilitate accurate screw placement.

Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases.

Study Design: Report of four collected cases.

Objective: The purpose of this report is to describe the presentation, diagnostic workup, treatment, and pathologic findings in four cases of lymphocytic reaction in patients receiving a metal-on-metal total disc replacement (TDR).

Summary Of Background Data: Metal-on-metal designs in hip arthroplasty have gained popularity because of decreased volumetric wear rates and theoretically increased implant longevity.

Are electrodiagnostic study findings related to a patient's response to epidural steroid injection?

Objective: To determine if improvements in pain after epidural steroid injections (ESIs) were related to electromyographic (EMG) findings in patients with radicular symptoms and clinical findings consistent with radiculopathy.

Design: Retrospective chart review.

Setting: Multisite spine clinic.

Effect of adverse events on low back surgery outcome: twenty-four-month follow-up results from a Food And Drug Administration investigational device exemptiontrial.

Study Design: This study was based on a post hoc analysis of data collected from a prospective FDA-regulated trial comparing total disc replacement to fusion surgery.

Objective: he purpose of this study was to determine if the occurrence of adverse events (AEs) had an impact on outcomes of low back surgery.

Summary Of Background Data: AEs are rigorously recorded during clinical trials primarily to evaluate the safety of the investigational device.