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New Orleans, LA, United States

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.

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.

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.

Bae H.W.,Cedars Sinai Spine Center | Kim K.D.,University of California at Davis | Nunley P.D.,Spine Institute of Louisiana | Hisey M.S.,The Texas Institute | And 7 more authors.
Spine | Year: 2015

Study Design. A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective. To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of Background Data. Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods. Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases. Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results. Preoperative characteristics were statistically similar for the 1-and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1-and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion. A 4-year post hoc comparison of 1-and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates. Copyright © 2015 Wolters Kluwer Health, Inc.

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 6 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.

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