Pumpkin Center, NC, United States
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PubMed | Av. Diagonal 491, University of Chile, Hospital Exequiel Gonzalez Cortes, New Vision and OrthoCarolina Spine Center
Type: | Journal: European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society | Year: 2016

A fresh frozen cadaver study was conducted.To report the cortical breach rate using the dynamic surgical guidance (DSG) probe versus traditional freehand technique for cervical lateral mass, cervical pedicle and cervical laminar screws.Nine male fresh frozen cadaveric torsos were utilized for this study. Each investigator was assigned three specimens that were randomized by fixation point, side and order of technique for establishing a screw pilot hole. The technique for screw hole preparation utilized was either a DSG probe in the on mode or in the off mode using a freehand technique popularized by Lenke et al. Levels instrumented included C1 lateral mass, C2 pedicle screws and lamina screws, and C6-T1 pedicle screws. Fluoroscopy and other navigational assistance were not used for screw hole preparation or screw insertion. All specimens were CT imaged following insertion of all screws. A senior radiologist evaluated all scans and determined that a misplaced screw was a breach of 2mm.A total of 104 drillings were performed, 52 with DSG and 52 without DSG There were 68 total pedicle drillings, 34 in each group. There were 18 drillings in the lamina and lateral mass. There was no significant difference between surgeons or between the left and right side. All breaches were in the pedicle, and none in the lamina or lateral mass. The breach rate for PG on was 6/68=8.96% (95% CI 3.69, 19.12%). The breach rate for PG off was 20/68=29.41% (95% CI 19.30, 41.87%). Of the 20 pedicle breaches in the non-DSG group, 7 were lateral and superior, 8 were lateral, 4 medial and 1 inferior. Of the six pedicle breaches in the DSG group, two were lateral/superior, two were lateral and two were medial in the pedicle.The dynamic surgical guidance probe is a safe tool to assist the surgeon with screw placement in the cervical spine. Additionally, the DSG potentially avoids the cumulative risks associated with fluoroscopy and provides real-time feedback to the surgeon allowing correction at the time of breach. Level of evidence Level IV.


Ghobrial G.M.,Thomas Jefferson University | Theofanis T.,Thomas Jefferson University | Darden B.V.,Orthocarolina Spine Center | Arnold P.,University of Kansas | And 2 more authors.
Neurosurgical Focus | Year: 2015

Object Unintended durotomy is a common occurrence during lumbar spinal surgery, particularly in surgery for degenerative spinal conditions, with the reported incidence rate ranging from 0.3% to 35%. The authors performed a systematic literature review on unintended lumbar spine durotomy, specifically aiming to identify the incidence of durotomy during spinal surgery for lumbar degenerative conditions. In addition, the authors analyzed the incidence of durotomy when minimally invasive surgical approaches were used as compared with that following a traditional midline open approach. Methods A MEDLINE search using the term "lumbar durotomy" (under the 2015 medical subject heading [MeSH] "cerebrospinal fluid leak") was conducted on May 13, 2015, for English-language medical literature published in the period from January 1, 2005, to May 13, 2015. The resulting papers were categorized into 3 groups: 1) those that evaluated unintended durotomy rates during open-approach lumbar spinal surgery, 2) those that evaluated unintended durotomy rates during minimally invasive spine surgery (MISS), and 3) those that evaluated durotomy rates in comparable cohorts undergoing MISS versus open-approach lumbar procedures for similar lumbar pathology. Results The MEDLINE search yielded 116 results. A review of titles produced 22 potentially relevant studies that described open surgical procedures. After a thorough review of individual papers, 19 studies (comprising 15,965 patients) pertaining to durotomy rates during open-approach lumbar surgery were included for analysis. Using the Oxford Centre for Evidence-Based Medicine (CEBM) ranking criteria, there were 7 Level 3 prospective studies and 12 Level 4 retrospective studies. In addition, the authors also included 6 studies (with a total of 1334 patients) that detailed rates of durotomy during minimally invasive surgery for lumbar degenerative disease. In the MISS analysis, there were 2 prospective and 4 retrospective studies. Finally, the authors included 5 studies (with a total of 1364 patients) that directly compared durotomy rates during open-approach versus minimally invasive procedures. Studies of open-approach surgery for lumbar degenerative disease reported a total of 1031 durotomies across all procedures, for an overall durotomy rate of 8.11% (range 2%-20%). Prospectively designed studies reported a higher rate of durotomy than retrospective studies (9.57% vs 4.32%, p = 0.05). Selected MISS studies reported a total of 93 durotomies for a combined durotomy rate of 6.78%. In studies of matched cohorts comparing open-approach surgery with MISS, the durotomy rates were 7.20% (34 durotomies) and 7.02% (68), respectively, which were not significantly different. Conclusions Spinal surgery for lumbar degenerative disease carries a significant rate of unintended durotomy, regardless of the surgical approach selected by the surgeon. Interpretation of unintended durotomy rates for lumbar surgery is limited by a lack of prospective and cohort-matched controlled studies. © AANS, 2015.


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.


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.


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.


Janssen M.E.,Center for Spinal Disorders Scientific Education and Research Institute | Zigler J.E.,The Texas Institute | Spivak J.M.,New York University | Delamarter R.B.,The Spine Institute | And 2 more authors.
The Journal of bone and joint surgery. American volume | Year: 2015

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). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores.RESULTS: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups.CONCLUSIONS: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease.LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.


Espiritu M.T.,Center for Neurosciences | Rhyne A.,OrthoCarolina Spine Center | Darden II B.V.,OrthoCarolina Spine Center
Journal of the American Academy of Orthopaedic Surgeons | Year: 2010

Dural tears are among the most commonly seen complications in spine surgery. Most studies in the literature indicate that long-term outcomes are not negatively affected, provided that the tears are diagnosed early and managed appropriately. Direct suture repair remains the preferred method for the management of durotomy caused by or found during surgery. However, recent literature reports encouraging results with sutureless repair. Understanding dural anatomy, dural healing, and cerebrospinal fluid dynamics is helpful in choosing among the available management options for dural tear.


Segebarth B.,OrthoCarolina Spine Center | Kurd M.F.,OrthoCarolina Spine Center | Haug P.H.,OrthoCarolina Research Institute | Davis R.,Health Partners
Journal of Spinal Disorders and Techniques | Year: 2015

Study Design: A retrospective cohort. Background: Degenerative spondylolisthesis (DS) with lumbar stenosis is a well-studied pathology and diagnosis is most commonly determined by a combination of magnetic resonance imaging (MRI) and standing radiographs. However, routine upright imaging is not universally accepted as standard in all practices. To the best of our knowledge, there has been no study investigating the incidence of missed diagnosis of DS evident only on standing lateral or dynamic radiographs when compared with sagittal alignment on MRI. Objective: The authors hypothesize that supine MRI evaluation alone in lumbar degenerative disease will significantly underestimate the incidence of DS. Secondary hypothesis is that there will be no significant difference in detecting spondylolisthesis when comparing dynamic flexion-extension radiographs to standing lateral radiographs. Methods: We retrospectively evaluated all patients presenting to spine clinic for degenerative lumbar conditions from July 2004 to July 2006 who had an MRI, upright lateral and flexionextension radiographs at our institution. The incidence of DS found on dynamic flexion-extension radiographs but not on MRI was determined. We then reviewed each and compared flexion-extension versus standing lateral views to determine whether there was any significant difference in detecting anterolisthesis. Results: Of 416 patients with eligible studies, 109 were found to have DS at levels L4-L5, L5-S1, or L3-L4 based on flexionextension radiographs. Of these, only 78 were found to have a corresponding spondylolisthesis on MRI, leaving 31/109 (28%) of DS levels undiagnosed on MRI. No additional anterolisthesis cases were detected on standing flexion-extension verses standing lateral radiographs. Conclusions: Routine standing lateral radiographs should be standard practice to identify DS, as nearly 1/3 of cases will be missed on supine MRI. This may have implications on whether or not an arthrodesis is performed on those patients requiring lumbar decompression. Flexion-extension radiographs demonstrated no added value compared with standing lateral x-rays for the purposes of diagnosing DS. © 2015 Wolters Kluwer Health, Inc. All rights reserved.


PubMed | OrthoCarolina Spine Center and OrthoCarolina Research Institute
Type: | Journal: European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society | Year: 2016

Many investigators have reported the financial conflicts of interest (COI), which could result in potential bias in the reporting of outcomes for patients undergoing total disc replacement (TDR) rather than anterior cervical discectomy and fusion (ACDF). This bias may be subconsciously introduced by the investigator in a non-blinded radiographic review. The purpose of this study was to determine if bias was present when a group of spine specialists rated adjacent segment degeneration (ASD) following cervical TDR or ACDF.Potential bias in the assessment of ASD was evaluated through the reviews of cervical radiographs (pre- and 6years post-operative) from patients participating in the ProDisc-C FDA trial (ProDisc-C IDE #G030059). The index level was blinded on all radiographs during the first review, but unblinded in the second. Five reviewers (a radiologist, two non-TDR surgeons, and two TDR surgeons), two of whom had a COI with the ProDisc-C trial sponsor, assessed ASD on a three point scale: yes, no, or unable to assess. Intra- and inter-rater reliabilities between all raters were assessed by the Kappa statistic.The intra-rater reliability between reviews was substantial, indicating little to no bias in assessing ASD development/progression. The Kappa statistics were 0.580 and 0.644 for the TDR surgeons (p<0.0001), 0.718 and 0.572 for the non-TDR surgeons (p<0.0001), and 0.642 for the radiologist (p<0.0001). Inter-rater reliability for the blinded review ranged from 0.316 to 0.607 (p<0.0001) and from 0.221 to 0.644 (p<0.0001) for the unblinded review.The knowledge of the surgical procedure performed did not bias the assessment of ASD.


PubMed | OrthoCarolina, OrthoCarolina Spine Center and OrthoCarolina Research Institute
Type: Journal Article | Journal: European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society | Year: 2016

The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7.We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed.Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7years. SF-36 scores were higher in the TDA group than ACDF group at 7years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group.The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

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