Spine Institute of Louisiana

New Orleans, LA, United States

Spine Institute of Louisiana

New Orleans, LA, United States
SEARCH FILTERS
Time filter
Source Type

Davis R.J.,Greater Baltimore Neurosurgical Inc. | Kim K.D.,University of California at Davis | Hisey M.S.,The Texas Institute | Hoffman G.A.,Orthopaedics Northeast | And 6 more authors.
Journal of Neurosurgery: Spine | Year: 2013

Object. Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine. Methods. This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi- C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients). Results. A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates. Conclusions. The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov). © Copyright 1944-2013 American Association of Neurological Surgeons.


Hisey M.S.,The Texas Institute | Bae H.W.,Spine Institute at St Johns Health Center | Davis R.J.,GBMC | Gaede S.,Oklahoma Spine and Brain Institute | And 7 more authors.
Journal of Spinal Disorders and Techniques | Year: 2015

Study Design: This was a prospective, randomized, controlled multicenter trial. Objective: The purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF). Summary of Background Data: ACDF has been the traditional treatment for symptomatic disk degeneration. Several studies found single-level TDR to be as safe and effective as ACDF at ≥2 years follow-up. Methods: Patients from 23 centers were randomized in a 2:1 ratio with 164 receiving the investigational device (Mobi-C Cervical Disc Prosthesis) and 81 receiving ACDF using an anterior plate and allograft. Patients were evaluated preoperatively and 6 weeks, 3, 6, 12, 18, 24, 36, and 48 months postoperatively. Outcome assessments included a composite success score, Neck Disability Index, visual analog scales assessing neck and arm pain, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent-segment degeneration. Results: The composite success rate was similar in the 2 groups at 48-month follow-up. Mean Neck Disability Index, visual analog scale, and SF-12 scores were significantly improved in early follow-up in both groups with improvements maintained throughout 48 months. On some measures, TDR had significantly greater improvement during early follow-up. At no follow-up were TDR scores significantly worse than ACDF scores. Subsequent surgery rate was significantly higher for ACDF compared with TDR (9.9% vs. 3.0%, P<0.05). Range of motion was maintained with TDR having a mean baseline value of 8 degrees compared with 10 degrees at 48 months. The incidence of adjacent-segment degeneration was significantly higher with ACDF at inferior and superior segments compared with TDR (inferior: 50% vs. 30%, P<0.025; superior: 53% vs. 34%, P<0.025). Conclusions: Significant improvements were observed in pain and function. TDR patients maintained motion and had significantly lower rates of reoperation and adjacent-segment degeneration compared with ACDF. This study supports the safety and efficacy of TDR in appropriately selected patients. Copyright © 2014 Wolters Kluwer Health, Inc. All rights reserved.


Davis R.J.,Greater Baltimore Neurosurgical Associates | Nunley P.D.,Spine Institute of Louisiana | Kim K.D.,University of California at Davis | Hisey M.S.,The Texas Institute | And 7 more authors.
Journal of Neurosurgery: Spine | Year: 2015

OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up. METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery. RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure. CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. ©AANS, 2015.


Ament J.D.,University of California at Davis | Yang Z.,University of California at Davis | Nunley P.,Spine Institute of Louisiana | Stone M.B.,Spine Institute of Louisiana | Kim K.D.,University of California at Davis
JAMA Surgery | Year: 2014

MAIN OUTCOMES AND MEASURES Incremental cost-effectiveness ratio of CTDR compared with ACDF.RESULTS A strong correlation (R2 = 0.6864; P < .001) was found by projecting a visual analog scale onto the Neck Disability Index. Cervical total disc replacement had an average of 1.58 QALYs after 24 months compared with 1.50 QALYs for ACDF recipients. Cervical total disc replacement was associated with $2139 greater average cost. The incremental cost-effectiveness ratio of CTDR compared with ACDF was $24 594 per QALY at 2 years. Despite varying input parameters in the sensitivity analysis, the incremental cost-effectiveness ratio value stays below the threshold of $50 000 per QALY in most scenarios (range, -$58 194 to $147 862 per QALY).CONCLUSIONS AND RELEVANCE The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $50 000 per QALY. This remains true with varying input parameters in a robust sensitivity analysis, reaffirming the stability of the model and the sustainability of this intervention.IMPORTANCE Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis, while preserving motion. While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease, a randomized clinical trial (RCT) suggested similar outcomes. Cost-effectiveness of this intervention has never been elucidated. Copyright 2014 American Medical Association. All rights reserved.OBJECTIVE To determine the cost-effectiveness of CTDR compared with ACDF.DESIGN, SETTING, AND PARTICIPANTS Datawere derived from an RCT that followed up 330 patients over 24 months. The original RCT consisted of multi-institutional data including private and academic institutions. Using linear regression for the current study, health states were constructed based on the stratification of the Neck Disability Index and a visual analog scale. Data from the 12-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-6D mapping algorithm. Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying 2012 Medicare reimbursement rates. The costs of complications and return-to-work data were also calculated. A Markov model was built to evaluate quality-adjusted life-years (QALYs) for both treatment groups. The model adopted a third-party payer perspective and applied a 3% annual discount rate. Patients included in the original RCT had to be diagnosed as having radiculopathy ormyeloradiculopathy at 2 contiguous levels from C3-C7 that was unresponsive to conservative treatment for at least 6 weeks or demonstrated progressive symptoms.


Nunley P.D.,Spine Institute of Louisiana | Jawahar A.,Spine Institute of Louisiana | Cavanaugh D.A.,Spine Institute of Louisiana | Gordon C.R.,Texas Spine and Joint Hospital | And 2 more authors.
Spine Journal | Year: 2013

Background context: Although several publications in the last decade have proved equality in safety and efficacy of the total disc replacement (TDR) to the anterior fusion procedure in cervical spine, the claim that TDR may reduce the incidence of adjacent segment disease (ASD) has not been corroborated by clinical evidence. Purpose: We attempt to predict the true incidence of symptomatic ASD after TDR surgery in the cervical spine at one or two levels at a median follow-up period of 4 years. Study design: A total of 763 patients were screened to participate in four different Food and Drug Administration device exemption trials for artificial cervical disc replacement at three collaborating institutions. Two hundred seventy-one patients qualified and enrolled in the trials. One hundred seventy-three randomized to receive artificial disc replacement surgery, and 167 have completed a 4-year or longer follow-up. Outcome measures: Patients experiencing cervical radiculopathy symptoms in the follow-up period were worked-up with clinical examinations, magnetic resonance imaging of the cervical spine, and other diagnostic studies. Once a clinical correlation was established with the imaging evidence of adjacent segment degeneration, a careful record was maintained to document the subsequent medical and/or surgical treatment received by these patients. Statistical analysis was performed to determine the true incidence of and factors affecting the ASD after cervical disc replacement in these patients. Results: Twenty-six patients (15.2%) were identified to satisfy our criteria for ASD at the median follow-up of 51 months, with the annual incidence of 3.1% as calculated by life tables. The actuarial 5-year freedom from ASD rate was 71.6%±0.6%, and the mean period for freedom from ASD was 70.4±2.1 months. Conclusions: The incidence of symptomatic ASD after cervical TDR is 3.1% annually regardless of the patient's age, sex, smoking habits, and design of the TDR device. The presence of osteopenia and lumbar degenerative disease significantly increase the risk of developing ASD after anterior cervical surgery. Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.


Coric D.,NC Associates | Nunley P.D.,Spine Institute of Louisiana | Guyer R.D.,The Texas Institute | Musante D.,NC Associates | And 5 more authors.
Journal of Neurosurgery: Spine | Year: 2011

Object. Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy. Methods. The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate. Results. A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group). Conclusions. Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.


The use of autogenous bone graft in spinal fusion is progressively declining. Different allografts including the human bone morphogenetic protein have been proposed to facilitate fusion rates but are associated with various adverse effects. Osteocel belongs to a new class of allograft tissue material that is a re-absorbable biomaterial with allogenic mesenchymal stem cells. The purpose of the present retrospective study was to analyze the clinical effectiveness of mesenchymal stem cells allograft (Osteocel") to achieve radiological arthrodesis in adult patients undergoing lumbar interbody fusion surgery for different indications. Fifty-two consecutive patients received lumbar interbody fusion at one (69%) or two contiguous (31%) levels of lumbar spine for various indications. The mean age was 50 (range, 27 to 77) years; 60% were females; 43% were habitual smokers and 21% had previously failed surgery at the index level(s). Outcome measures: Radiographic analyses of fusion by plain films and CT scans. Procedures performed were circumferential fusion (67%), ALIF (17%) and TLIF (16%). Followup radiographic data was analyzed to establish arthrodesis versus failure (pseudarthrosis), number of months until achievement of fusion, and possible factors affecting the fusion rate. Followup ranged from 8 to 27 (median, 14) months. Solid arthrodesis was achieved in 92.3% of patients at median followup time of 5 months (95% Cl; range, 3 to 11 months). Kaplan-Meier survival curves and Mantle-Cox test were conducted to assess the effect of various factors on the rate of fusion. Statistics showed that increasing age (older than 50 years) (p = 0.017) and habitual smoking (p = 0.015) delayed the fusion time and increased the risk of pseudarthrosis. The use of Osteocel allograft is safe and effective in adult patients undergoing lumbar interbody spinal fusion procedure. Increased age and habitual smoking delays fusion but gender, previous surgery at the index level, type of procedure and number of levels do not affect the fusion rates.


Cavanaugh D.A.,Spine Institute of Louisiana
The Journal of the Louisiana State Medical Society : official organ of the Louisiana State Medical Society | Year: 2010

OBJECTIVE AND IMPORTANCE: Ganglioneuromas are rare benign tumors of the neural crest occurring in early childhood. They are occasionally diagnosed in young adults due to their mass-effect on adjacent structures. We report a case of ganglioneuroma incidentally diagnosed in an adult man. CLINICAL PRESENTATION: A 41-year-old man presented with left-sided cervical radiculopathy symptoms due to degenerative disc disease at the C5-6 and C6-7 levels. The diagnostic radiology work-up revealed a mass in the left side of the neck between the carotid artery and jugular vein. INTERVENTION: Surgical excision of the mass was performed and the histological diagnosis of ganglioneuroma was established. The patient developed left-sided Horner's syndrome post-operatively. CONCLUSION: The present case suggests that these tumors may have insidious presence in the adult population, and therefore, should be considered in the differential diagnosis of a lateral neck mass in asymptomatic adult patients.


Nunley P.D.,Spine Institute of Louisiana | Jawahar A.,Spine Institute of Louisiana | Kerr E.J.,Spine Institute of Louisiana | Gordon C.J.,The Texas Institute | And 4 more authors.
Spine | Year: 2012

Study Design.: Prospective randomized clinical trials. Objective.: To compare the outcome data with respect to clinical success rates and incidence of adjacent level disease (ALD) in patients after total disc arthroplasty (TDA) or anterior cervical fusion (ACDF) for 1- and 2-level cervical disc disease. Summary of Background Data.: Previously published studies have provided evidence that ACDF procedure for cervical degenerative disc disease (DDD) may increase the stress on the nonoperated adjacent cervical segments, thus possibly increasing the risk of degeneration at these levels. The theoretical assumption that TDA may reduce the incidence of future ALD by preserving motion at the affected segments has, however, never been validated by clinical evidence. Methods.: One hundred seventy patients with established symptomatic cervical disc disease at 1 or 2 levels participated in 3 prospective randomized clinical trials at 2 institutions. Participating subjects were randomized to receive TDA (treatment; n = 113) or ACDF (control; n = 57) by 6 independent investigating surgeons. Visual analogue pain scores (0-100), Neck Disability Index, neurological examination, and cervical spine radiographs were collected at enrollment and then 6 weeks and 3, 6, 12, 24, 36, and 48 months after surgery. Patients with persistent symptoms during the follow-up period were investigated for adjacent segment disease (ASD) with computed tomography/magnetic resonance imaging of the cervical spine, neurophysiology, and subsequent active interventions. Results.: At the median follow-up of 42 months (range: 28-54 months), 9 (14.3%) ACDF and 19 (16.8%) TDA patients developed and were actively treated for ASD. Osteopenia dust energy x-ray absorptiometry T scores of -1.5 to -2.4) (P = 0.04; 95% confidence interval [CI]: 0.007-0.223) and concurrent lumbar degenerative disease (P = 0.02; 95% CI: 0.003-0.196) significantly increased the risk of ASD. Conclusion.: The risk of developing adjacent segment degeneration was equivalent at median 38 months after both ACDF and TDA procedures in cervical DDD. Osteopenia and concurrent lumbar DDD significantly increase the risk of ALD. © 2012 Lippincott Williams and Wilkins.


Jawahar A.,Spine Institute of Louisiana | Cavanaugh D.A.,Spine Institute of Louisiana | Kerr III E.J.,Spine Institute of Louisiana | Birdsong E.M.,Spine Institute of Louisiana | Nunley P.D.,Spine Institute of Louisiana
Spine Journal | Year: 2010

Background context: Advancements in the philosophy of "motion preservation" have led to the use of total disc arthroplasty (TDA) as an alternative to fusion for degenerative disc disease (DDD) in the cervical spine. A commonly proposed theory is that TDA could reduce the incidence of adjacent segment disease. All the published clinical studies for TDA discuss the "equal efficacy" results of different investigational device exemption (IDE) trials between TDA and anterior cervical discectomy and fusion (ACDF) but have not addressed the issue of adjacent segment disease. Purpose: To present the comparison of outcome data with respect to clinical success rates, symptom-free period, and incidence of adjacent segment disease in 93 patients with one- and two-level cervical DDD treated with TDA or ACDF in three different Food and Drug Administration (FDA) investigational trials. Study design: Prospective, randomized, FDA IDE trials. Patient sample: Ninety-three patients with established symptomatic one-or two-level cervical disc disease who failed to respond to conservative treatment were randomized to receive TDA (59) or ACDF (34) as part of clinical trials involving three different artificial discs at our institution. Subjects were blind to the assigned group until after the surgery. Outcome measures: Visual analog pain score (VAS), Neck Disability Index, and cervical spine radiographs were collected at 6 weeks and at 3, 6, 12, 24, 36, and 48 months after surgery. Method: Success of the index surgery was assessed based on outcome measures at the seven data points. Success was defined as reduction by more than 30 points in both VAS and Neck Disability Index, absence of neurological deficits, and no further intervention at the index level. Adjacent segment disease was established by radiology, neurophysiology, and subsequent interventions administered to the patients. Results: At median follow-up of 37 months (range, 24-49 months), 64 (25 ACDF and 39 TDA) patients satisfied the criteria for clinical success. Neck Disability Index was a better predictor of outcome than pain score (p<.05). Sixteen percent of TDA patients and 18% ACDF patients developed adjacent segment degeneration and were treated actively (p=.3). Concurrent lumbar DDD significantly increased the risk of adjacent segment degeneration (p=.01). Age, gender, smoking habits, and number of levels at index surgery had no predictive value. Conclusion: Total disc arthroplasty is equivalent to ACDF for providing relief from symptoms in the treatment of one- and two-level DDD of cervical spine. The risk of developing adjacent segment degeneration is equivalent after both procedures but is significantly higher in patients with concurrent DDD in lumbar spine. © 2010 Elsevier Inc. All rights reserved.

Loading Spine Institute of Louisiana collaborators
Loading Spine Institute of Louisiana collaborators