Darden B.V.,OrthoCarolina Spine Center
Seminars in Spine Surgery | Year: 2012
ProDisc-C cervical disc arthroplasty is a prosthesis that has a cobalt chrome/polyethylene bearing surface and is semi-constrained. It was developed based on the design of the ProDisc-L lumbar disc arthroplasty. ProDisc-C cervical disc arthroplasty has undergone the FDA investigation device exemption trial. The results from this trial at two years as well as a four year clinical study of the same patients as well as continued access patients will be reported. Further studies in the literature concerning heterotopic ossification as well as biomechanical and radiographic evaluations of ProDisc-C are reported. © 2012 Elsevier Inc.
Le M.E.,000 Blythe Boulevard |
Kurd M.F.,OrthoCarolina Spine Center
Current Reviews in Musculoskeletal Medicine | Year: 2014
Medtronic's biologic, Infuse (rhBMP-2), was approved by the FDA in 2002. Since its approval, a whirlwind of controversy developed culminating in an investigation by the Senate Finance committee. These events led to a landmark agreement between Medtronic and Yale University to perform a comprehensive and unbiased analysis of all patient related data. The project was named the Yale Open Data Access (YODA). The purpose of this article is to evaluate the results of the YODA project and determine what is clinically meaningful. © 2014 Springer Science+Business Media.
Bible J.E.,Penn State Milton rshey Medical Center |
Kay H.F.,Vanderbilt University |
Shau D.N.,Vanderbilt University |
O'Neill K.R.,Vanderbilt University |
And 2 more authors.
Spine | Year: 2015
Study Design. Prospective study. Objective. Assess which patient factors are associated with patient satisfaction scores in the outpatient spine clinic setting. Summary of Background Data. Patient satisfaction has become an important component of quality assessments, and thereby pay-for-performance metrics, made by government, hospitals, and insurance providers. Methods. During a 7-month period, 200 patients were contacted via phone within 3 weeks of a new patient encounter with 1 of 11 spine providers. A standardized patient satisfaction phone survey consisting of 25 questions, answered using a 1-10 scale, was then administered. Patient demographics, medical/social history, and previous treatment were prospectively recorded. Potential associations between these patient factors and 3 outcomes of interest were investigated: (1) provider satisfaction, (2) overall clinic visit satisfaction, and (3) overall quality of care during clinic visit. Results. Younger age, less formal education, and smoking were associated with diminished provider satisfaction, overall clinic visit satisfaction, and perceived overall quality of care (P ≤ 0.0001). Male patients were significantly less satisfied with their clinic visit compared with females (P = 0.029). Those treated under a worker's compensation claim were significantly less satisfied with their provider and overall quality of care (P ≤ 0.02). Marital status, working status, mental health history, travel distance, pain characteristics, previous treatments, and current narcotic use were not significant determinants of patient satisfaction (P > 0.05). Conclusion. This study found that those patients who were younger, with less formal education, and active smokers had lower patient satisfaction scores. Because patient satisfaction is increasingly being used in assessments of quality of care, it is essential that these factors be considered when evaluating a given provider's practice. This information is important to providers by helping guide individualized patient interactions while in clinic, as well as, the various agencies collecting satisfaction scores allowing them to account for potential sampling bias. © 2015, Wolters Kluwer Health, Inc. All rights reserved.
O'Boynick C.P.,Saint Louis University |
Kurd M.F.,OrthoCarolina Spine Center |
Darden II B.V.,OrthoCarolina Spine Center |
Vaccaro A.R.,Thomas Jefferson University |
Fehlings M.G.,University of Toronto
Neurosurgical Focus | Year: 2014
The understanding of the optimal surgical timing for stabilization in thoracolumbar fractures is severely limited. Thoracolumbar spine fractures can be devastating injuries and are often associated with significant morbidity and mortality. The role of early surgical stabilization (within 48-72 hours of injury) as a vehicle to improve outcomes in these patients has generated significant interest. Goals of early stabilization include improved neurological recovery, faster pulmonary recovery, improved pain control, and decreased health care costs. Opponents cite the potential for increased bleeding, hypotension, and the risk of further cord injury as a few factors that weigh against early stabilization. The concept of spinal cord injury and its relationship to surgical timing remains in question. However, when neurological outcomes are eliminated from the equation, certain measures have shown positive influences from prompt surgical fixation. Early fixation of thoracolumbar spine fractures can significantly decrease the duration of hospital stay and the number of days in the intensive care unit. Additionally, prompt stabilization can reduce rates of pulmonary complications. This includes decreased rates of pneumonia and fewer days on ventilator support. Cost analysis revealed as much as $80,000 in savings per patient with early stabilization. All of these benefits come without an increase in morbidity or evidence of increased mortality. In addition, there is no evidence that early stabilization has any ill effect on the injured or uninjured spinal cord. Based on the existing data, early fixation of thoracolumbar fractures has been linked with positive outcomes without clear evidence of negative impacts on the patient's neurological status, associated morbidities, or mortality. These procedures can be viewed as "damage control" and may consist of simple posterior instrumentation or open reductions with internal fixation as indicated. Based on the current literature it is advisable to proceed with early surgical stabilization of thoracolumbar fractures in a well-resuscitated patient, unless extenuating medical conditions would prevent it. © AANS, 2014.
Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients
Delamarter R.B.,Cedars Sinai Medical Center |
Murrey D.,OrthoCarolina Spine Center |
Janssen M.E.,Spinal USA |
Goldstein J.A.,New York University |
And 3 more authors.
SAS Journal | Year: 2010
Background: Cervical total disk replacement (TDR) is intended to address pain and preserve motion between vertebral bodies in patients with symptomatic cervical disk disease. Two-year follow-up for the ProDisc-C (Synthes USA Products, LLC, West Chester, Pennsylvania) TDR clinical trial showed non-inferiority versus anterior cervical discectomy and fusion (ACDF), showing superiority in many clinical outcomes. We present the 4-year interim follow-up results. Methods: Patients were randomized (1:1) to ProDisc-C (PDC-R) or ACDF. Patients were assessed preoperatively, and postoperatively at 6 weeks and 3, 6, 12, 18, 24, 36, and 48 months. After the randomized portion, continued access (CA) patients also underwent ProDisc-C implantation, with follow-up visits up to 24 months. Evaluations included Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain/satisfaction, and radiographic and physical/neurologic examinations. Results: Randomized patients (103 PDC-R and 106 ACDF) and 136 CA patients were treated at 13 sites. VAS pain and NDI score improvements from baseline were significant for all patients (P < .0001) but did not differ among groups. VAS satisfaction was higher at all time points for PDC-R versus ACDF patients (P = .0499 at 48 months). The percentage of patients who responded yes to surgery again was 85.6% at 24 months and 88.9% at 48 months in the PDC-R group, 80.9% at 24 months and 81.0% at 48 months in the ACDF group, and 86.3% at 24 months in the CA group. Five PDC-R patients (48 months) and no CA patients (24 months) had index-level bridging bone. By 48 months, approximately 4-fold more ACDF patients required secondary surgery (3 of 103 PDC-R patients [2.9%] vs 12 of 106 ACDF patients [11.3%], P = .0292). Of these, 6 ACDF patients (5.6%) required procedures at adjacent levels. Three CA patients required secondary procedures (24 months). Conclusions: Our 4-year data support that ProDisc-C TDR and ACDF are viable surgical options for symptomatic cervical disk disease. Although ACDF patients may be at higher risk for additional surgical intervention, patients in both groups show good clinical results at longer-term follow-up. © 2010 Elsevier Inc.