Treatment of failed cervical total disc replacements in a series of 53 cases and description of a management strategy.

Purpose: To describe modes of failure of cervical TDR, their related treatment strategies, and to describe a management strategy for the treatment of failed cervical TDR.

Methods: This retrospective study was based on a consecutive series of 53 cervical TDR patients who underwent removal or revision surgery. Chart review was conducted to collect general descriptive data, reasons for TDR removal/revision, duration from index implantation to re-operation, and the subsequent procedure performed.

Clinical Outcome of Lumbar Hybrid Surgery in a Consecutive Series of Patients With Long-term Follow-up.

Study Design: This was a retrospective study combined with attempted prospective patient contact to collect current data.

Objective: The purpose of this study was to investigate the long-term clinical outcomes of patients undergoing lumbar hybrid surgery (total disk replacement (TDR) at one level and fusion at an adjacent level.

Summary Of Background Data: Many patients with symptomatic lumbar disk degeneration are affected at more than one level.

Removals and Revisions of Cervical Total Disc Replacement Devices in a Consecutive Series of 1626 Patients Beginning With the First Case Experience in 2003.

Study Design: Retrospective cohort study.

Objective: The purpose of this study was to investigate the rate of cervical total disc replacement (TDR) device removal or revision.

Background: Cervical TDR has gained acceptance as an alternative to anterior cervical discectomy and fusion in appropriately selected patients.

Prosthesis design and likelihood of achieving physiological range of motion after cervical disc arthroplasty: analysis of range of motion data from 1,173 patients from 7 IDE clinical trials.

Background Context: The functional goals of cervical disc arthroplasty (CDA) are to restore enough range of motion (ROM) to reduce the risk of accelerated adjacent segment degeneration but limit excessive motion to maintain a biomechanically stable index segment. This motion-range is termed the "Physiological mobility range." Clinical studies report postoperative ROM averaged over all study subjects but they do not report what proportion of reconstructed segments yield ROM in the Physiological mobility range following CDA surgery.

Lumbar Total Disk Replacement Device Removals and Revisions Performed During a 20-Year Experience with 2141 Patients.

Study Design: This was a retrospective study with prospective patient contact attempted to collect current data.

Objective: The purpose was to investigate the incidence and reasons for lumbar total disk replacement (TDR) removal or revision.

Summary Of Background Data: A concern regarding lumbar TDR was safety, particularly the need for device removal or revision.

Impact of previous lumbar spine surgery on the outcome of lumbar total disc replacement: analysis of prospective 5-year follow-up study data.

Purpose: It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery.

Methods: Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration.

Evaluation of Anterior Lumbar Interbody Fusion Performed Using a Stand-Alone, Integrated Fusion Cage.

Background: Anterior lumbar interbody fusion (ALIF) has been performed for many years. Often, posterior supplemental fixation has been used to provide additional stability to the operated segment. Interbody implants have evolved to incorporate unique designs, polyetheretherketone, integrated screws, and surface texture.

In which cases do surgeons specializing in total disc replacement perform fusion in patients with symptomatic lumbar disc degeneration?

Purpose: The purpose of this study was to investigate reasons and their frequency for why spine surgeons subspecializing in total disc replacement (TDR) performed lumbar fusion rather than TDR.

Methods: The study was based on a consecutive series of 515 patients undergoing lumbar TDR or fusion during a 5-year period by three surgeons specializing in TDR. For each fusion patient, the reason for not performing TDR was recorded.

Segmental Motion of Cervical Arthroplasty Leads to Decreased Adjacent-Level Degeneration: Analysis of the 7-Year Postoperative Results of a Multicenter Randomized Controlled Trial.

Background: Cervical artificial disc replacement (C-ADR) has become a common and accepted surgical treatment for many patients with cervical disc degeneration/herniation and radiculopathy who have failed nonoperative treatment. Midterm follow-up studies of the original investigational device exemption trials comparing C-ADR to traditional anterior cervical discectomy and fusion (ACDF) have revealed C-ADR patients have less adjacent-level disease and fewer reoperations at 5 to 7 years. The purpose of this study was to examine the relationship of radiographic adjacent-level disease (R-ALD) with the amount of index-level segmental range of motion (ROM) in C-ADR patients using the long-term follow-up data from the ProDisc-C investigational device exemption trial.

Cervical Disc Arthroplasty: Rationale and History.

Biomechanical studies have demonstrated that cervical fusion results in increased motion and intradiscal pressures at adjacent levels. Cervical disc arthroplasty (CDA) is an alternative treatment for cervical radiculopathy and myelopathy resulting from degenerative disc disease. By maintaining segmental motion, surgeons hope to avoid some of the primary drawbacks of anterior cervical discectomy and fusion (ACDF), such as pseudoarthrosis and adjacent segment disease.

Analysis of re-operations after cervical total disc replacement in a consecutive series of 535 patients receiving the ProDisc-C device.

Introduction: One important factor in evaluating the safety of an implant is the rate of subsequent surgery and the reasons for surgery, particularly those that are related to possible problems with the implant. The purpose of this study was to determine the overall re-operation rate (including revisions, removals, device-related, procedure-related, adjacent segment, and others) for a large consecutive series of cervical TDR patients beginning with the first case experience, using a single device at a single institution.

Methods: Surgery records were reviewed to identify cervical TDR patients and those who underwent subsequent surgery.

Screw-Related Complications After Instrumentation of the Osteoporotic Spine: A Systematic Literature Review With Meta-Analysis.

Study Design: Systematic literature review with meta-analysis.

Objective: Osteoporosis is common in elderly patients, who frequently suffer from spinal fractures or degenerative diseases and often require surgical treatment with spinal instrumentation. Diminished bone quality impairs primary screw purchase, which may lead to loosening and its sequelae, in the worst case, revision surgery.

In which cases do surgeons specializing in total disc replacement perform fusion in patients with cervical spine symptoms?

Purpose: The purpose was to investigate reasons and their frequency for why total disc replacement (TDR) specialty surgeons performed anterior cervical discectomy and fusion (ACDF) rather than TDR.

Methods: A consecutive series of 464 patients undergoing cervical spine surgery during a 5-year period by three TDR specialty surgeons was reviewed. For each ACDF, the reason for not performing TDR was recorded.

Progression of Adjacent-level Degeneration After Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients With Available Radiographs From a Prospective Study With 5-year Follow-up.

Study Design: Post-hoc analysis of 5-year follow-up data from a randomized, multicenter trial.

Objective: The aim of this study was to investigate the incidence of progression in radiographic adjacent-level degeneration (ΔALD) from preoperative assessment to 5 years after total disc replacement (TDR) and the relationship of these changes with range of motion and clinical adjacent-level disease. A secondary objective was to compare adjacent-level degeneration (ALD) outcomes between TDR and fusion.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up.

Introduction: There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C(®) with ACDF at 5-year follow-up.

Comparison of 1-Level Versus 2-Level Anterior Cervical Discectomy and Fusion: Clinical and Radiographic Follow-Up at 60 Months.

Study Design: This study represents a posthoc analysis of data collected from 2 control arms of a prospective, randomized study.

Objective: The purpose of this study was to compare results of patients undergoing 1- versus 2-level anterior cervical discectomy and fusion (ACDF).

Summary Of Background Data: For single-level ACDF, reported outcomes have generally been good; however, results for 2 levels have been less consistent.

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial.

Introduction: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression.

Seven-year cost-effectiveness of ProDisc-C total disc replacement: results from investigational device exemption and post-approval studies.

OBJECTIVE The purpose of this study was to evaluate the 7-year cost-effectiveness of cervical total disc replacement (CTDR) versus anterior cervical discectomy and fusion (ACDF) for the treatment of patients with single-level symptomatic degenerative disc disease. A change in the spending trajectory for spine care is to be achieved, in part, through the selection of interventions that have been proven effective yet cost less than other options. This analysis complements and builds upon findings from other cost-effectiveness evaluations of CTDR through the use of long-term, patient-level data from a randomized study.

Restoration of Cervical Alignment is Associated with Improved Clinical Outcome after One and Two Level Anterior Cervical Discectomy and Fusion.

Background: Anterior cervical discectomy and fusion (ACDF) remains the standard of care for patients with cervical radiculopathy who are unresponsive to conservative care. However, the maintenance and restoration of cervical alignment as a predictive factor for outcome has not yet been fully evaluated. The purpose of this study was to evaluate the impact of maintaining or restoring cervical alignment on one and two level ACDF patients' outcome.

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.

Background: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7.

Methods: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106).

Development of a novel radiographic measure of lumbar instability and validation using the facet fluid sign.

Background: Lumbar spinal instability is frequently referenced in clinical practice and the scientific literature despite the lack of a standard definition or validated radiographic test. The Quantitative Stability Index (QSI) is being developed as a novel objective test for sagittal plane lumbar instability. The QSI is calculated using lumbar flexion-extension radiographs.

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.

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.