Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: Two-year results from the prospective, randomized, multicenter, food and drug administration investigational device exemption trial
Davis R.J.,Greater Baltimore Neurosurgical Associates |
Errico T.J.,New York University |
Bae H.,Spine Institute |
Auerbach J.D.,Bronx Lebanon Hospital Center
Spine | Year: 2013
STUDY DESIGN.: Prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial. OBJECTIVE.: To evaluate the safety and efficacy of Coflex interlaminar stabilization compared with posterior spinal fusion in the treatment of 1-and 2-level spinal stenosis and degenerative spondylolisthesis. SUMMARY OF BACKGROUND DATA.: Long-term untoward sequelae of lumbar fusion for stenosis and degenerative spondylolisthesis have led to the search for motion-preserving, less-invasive alternatives. METHODS.: Three hundred twenty-two patients (215 Coflex and 107 fusions) from 21 sites in the United States were enrolled between 2006 and 2010. Subjects were randomized to receive laminectomy and Coflex interlaminar stabilization or laminectomy and posterolateral spinal fusion with spinal instrumentation in a 2:1 ratio. Overall device success required a 15-point reduction in Oswestry Disability Index, no reoperations, no major device-related complications, and no postoperative epidural injections. RESULTS.: Patient follow-up at minimum 2 years was 95.3% and 97.2% in the Coflex and fusion control groups, respectively. Patients taking Coflex experienced significantly shorter operative times (P < 0.0001), blood loss (P < 0.0001), and length of stay (P < 0.0001). There was a trend toward greater improvement in mean Oswestry Disability Index scores in the Coflex cohort (P = 0.075). Both groups demonstrated significant improvement from baseline in all visual analogue scale back and leg parameters. Patients taking Coflex experienced greater improvement in Short-Form 12 physical health outcomes (P = 0.050) and equivalent mental health outcomes. Coflex subjects experienced significant improvement in all Zurich Claudication Questionnaire outcomes measures compared with fusion (symptom severity [P = 0.023]; physical function [P = 0.008]; satisfaction [P = 0.006]). Based on the Food and Drug Administration composite for overall success, 66.2% of Coflex and 57.7% of fusions succeeded (P = 0.999), thus demonstrating noninferiority. The overall adverse event rate was similar between the groups, but Coflex had a higher reoperation rate (10.7% vs. 7.5%, P = 0.426). At 2 years, fusions exhibited increased angulation (P = 0.002) and a trend toward increased translation (P = 0.083) at the superior adjacent level, whereas Coflex maintained normal operative and adjacent level motion. CONCLUSION.: Coflex interlaminar stabilization is a safe and efficacious alternative, with certain advantages compared with lumbar spinal fusion in the treatment of spinal stenosis and low-grade spondylolisthesis. © 2013 Lippincott Williams & Wilkins.
Bae H.W.,Cedars Sinai Medical Center |
Zhao L.,Cedars Sinai Medical Center |
Kanim L.E.A.,Cedars Sinai Medical Center |
Wong P.,Spine Institute |
And 2 more authors.
Journal of Bone and Joint Surgery - Series A | Year: 2013
Background: Reliable and rapid bone formation is the goal of biologics and cell-based spinal fusion technologies. While no cell-based therapy alone has been successful, recombinant human bone morphogenetic protein-2 (rhBMP-2) has been successfully used in a wide spectrum of patients undergoing a variety of spinal fusion procedures since its approval by the United States Food and Drug Administration (FDA) in 2002. However, the question remains how to improve the biologic efficiency, or osteoinductivity, of rhBMP-2 for successful application in the most challenging patients undergoing spinal fusion or to reduce the doses currently required. The present study investigated how varying the cellular environments through the addition of freshly harvested bone marrow aspirate (BMA) modulates rhBMP-2 efficiency. Methods: An L4-L5 posterolateral intertransverse process spinal fusion procedure was performed in Lewis rats. The implants were a subeffective concentration of 0.006 mg/mL of rhBMP-2/two absorbable collagen sponges (ACS) plus directly applied fresh syngeneic BMA transplants (n = 18), 0.006-mg/mL rhBMP-2/two ACS/side (n = 12), 0.006-mg/mL rhBMP-2/one ACS/side (n = 12), or BMA/one ACS/side (n = 6). Rats were killed at eight weeks and were evaluated with use of manual palpation, radiographs, and biomechanical testing. Results: BMA plus 0.006-mg/mL rhBMP-2/ACS significantly increased the L4-L5 fusion rate to 89% (sixteen of eighteen) compared with a base fusion rate of 33% (four of twelve) to 50% (six of twelve) for rats implanted with rhBMP-2/ACS (p < 0.05), with no difference in strength or stiffness between conditions. No fusion or bone formation was observed in the six rats that received BMA/ACS alone. Conclusions: Less rhBMP-2 was needed for effect when mixed with BMA. A nearly twofold increase in the fusion rate was found when BMA was mixed with a deliberate subeffective concentration of rhBMP-2. There was no improvement in terms of fusion strength or stiffness. Copyright © 2014 By The Journal of Bone and Joint Surgery, Incorporated.
Aquilina K.,Frenchay Hospital |
Clarke D.F.,University of Tennessee Health Science Center |
Wheless J.W.,University of Tennessee Health Science Center |
Boop F.A.,Spine Institute
Journal of Neurosurgery: Pediatrics | Year: 2010
Temporal lobe encephaloceles can be associated with temporal lobe epilepsy. The authors report on the case of an adolescent with multiple microencephaloceles, in the anterolateral middle fossa floor, identified at surgery (temporal lobectomy) for intractable partial-onset seizures of temporal origin. Magnetic resonance imaging revealed only hippocampal atrophy. Subdural electrodes demonstrated ictal activity arising primarily from the anterior and lateral temporal lobe, close to the microencephaloceles, spreading to the anterior and posterior mesial structures. Pathological examination revealed diffuse temporal gliosis involving the hippocampus, together with microdysgenesis of the amygdala. The literature on epilepsy secondary to encephaloceles is reviewed and the contribution of the microencephaloceles to the seizure disorder in this patient is discussed.
Prospective, randomized, multicenter food and drug administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: Results at twenty-four months
Delamarter R.,Spine Institute |
Zigler J.E.,The Texas Institute |
Balderston R.A.,Pennsylvania Hospital |
Cammisa F.P.,Hospital for Special Surgery |
And 2 more authors.
Journal of Bone and Joint Surgery - Series A | Year: 2011
Background: Disc replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L total disc replacement as compared with spinal fusion for the treatment of degenerative disc disease at two contiguous vertebral levels from L3 to S1. Methods: A total of 237 patients were treated in a randomized controlled trial designed as a non-inferiority study for regulatory application purposes. Blocked randomization was performed with use of a 2:1 ratio of total disc arthroplasty to circumferential arthrodesis. Evaluations, including patient self-assessments, physical and neurological examinations, and radiographic examinations, were performed preoperatively, six weeks postoperatively, and three, six, twelve, eighteen, and twenty-four months postoperatively. Results: At twenty-four months, 58.8% (eighty-seven) of 148 patients in the total disc replacement group were classified as a statistical success, compared with 47.8% (thirty-two) of sixty-seven patients in the arthrodesis group; non-inferiority was demonstrated. The mean Oswestry Disability Index in both groups significantly improved from baseline (p < 0.0001); the mean percentage improvement for the total disc replacement group was significantly better than that for the arthrodesis group (p = 0.0282). An established clinical criterion for success, a ≥15-point improvement in the Oswestry Disability Index from baseline, occurred in 73.2% (109) of 149 patients in the total disc replacement group and 59.7% (thirty-seven) of sixty-two patients in the arthrodesis group. The Short Form-36 physical component scores were significantly better for the total disc replacement group as compared with the arthrodesis group (p = 0.0141 at twenty-fourmonths). Visual analog scale scores for satisfaction significantly favored total disc replacement from three to twenty-four months. At twenty-four months, 78.2% (111) of 142 patients in the total disc replacement group and 62.1% (thirty-six) of fifty-eight patients in the arthrodesis group responded "yes" when asked if theywould have the same surgery again. Lumbar spine range ofmotion on radiographs averaged 7.8° at the superior disc and 6.2° at the inferior disc in patients with total disc replacement. Reduction in narcotics usage significantly favored the total disc replacement group at twenty-four months after surgery (p = 0.0020). Conclusions: Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence. Copyright © 2011 by The Journal of Bone and Joint Surgery, Incorporated.
Parent S.,University of Montreal |
Dimar J.,Spine Institute |
Dekutoski M.,Mayo Medical School |
Roy-Beaudry M.,University of Montreal
Spine | Year: 2010
Study Design. Systematic review. Objective. The objective of this systematic review was to identify the unique features associated with pediatric spinal cord injury (SCI) with the intention of determining the most effective spinal stabilization methods and identifying the optimum treatment for post-traumatic spinal deformity in pediatric patients with a SCI. Summary of Background Data. Spinal injuries occur in 1.99/100,000 children, 10% are under 15 years, 60% to 80% occur in the cervical spine, and 5.4% to 34% in the thoracolumbar spine. The most frequent incident of spinal injury (50%-56%) occurs during motor vehicle accidents. Methods. A systematic review of the English language literature explored articles published between 1950 and 2009. Electronic databases (Medline and Embase) and reference lists of key articles were searched to identify unique features of pediatric SCI based on 2 questions: (1) "What is the most effective means to achieve spinal stabilization in pediatric patients with a SCI?" and (2) "What is the most effective treatment of post-traumatic spinal deformities in pediatric patients with a SCI?" Three Spinal Trauma Study Group faculty members assessed the level of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria and disagreements were resolved by a modified Delphi consensus. Results. No Level 1 or 2 evidence articles were discovered. Question 1 was addressed by 417 abstracts; from those 15 were selected for inclusion. This literature proved to be controversial, mostly focused on the adult population, pediatric series were retrospective, and most treatments were based on adult experience. The evidence supporting stabilization of the spine in the pediatric SCI population is very low for both the cervical and thoracic spinal regions. Question 2 was discussed in 517 abstracts; 8 relevant articles were selected. The principal key points, regarding the most effective treatment of post-traumatic spinal deformity in the pediatric SCI patients, suggest that the deformity should be prevented before the age of 10 to 12 years, younger SCI patients are unfavorable, nearly 100% of patients with SCI will develop a deformity, and brace treatment is generally recommended. Current evidence in support of brace use is very low. Conclusion. Despite the lack of well-designed prospective studies to establish the efficacy of instrumentation in these cases, there remains very low evidence that supports the use of instrumentation in unstable pediatric spines to prevent neurologic injury and maintain spinal alignment. The very low evidence of benefits from early bracing clearly outweighs the risks and complications associated with its use. Close monitoring should be initiated early so as to delay surgical correction as late as possible. There is very low evidence to support the use of surgery for the treatment of deformity triggered by a SCI. There may be evidence suggesting that the correction techniques used for neuromuscular deformities are useful for SCI patients. In conclusion, there is a strong recommendation for the use of instrumentation in the unstable pediatric spinal injured population, and there is a strong recommendation for traditional neuromuscular spinal deformity treatment techniques to be adopted as a treatment of progressive spinal deformities after a neurologic injury. © 2010, Lippincott Williams & Wilkins.