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.
Glandt M.,Bronx Lebanon Hospital Center |
Raz I.,Hebrew University of Jerusalem
Journal of Obesity | Year: 2011
Obesity now presents one of the biggest health problems of our times. Diet and exercise are best for both prevention and treatment; unfortunately, both require much discipline and are difficult to maintain. Medications offer a possible adjunct, but their effect is modest, they are limited by side effects, and the weight loss lasts only as long as the drug is being taken, since as soon as treatment is stopped, the weight is regained. Sibutramine, a sympathomimetic medication which was available for long-term treatment, is the most recent of the drugs to be withdrawn from the market due to side effects; in this case it was an increased risk of cardiovascular events. This paper reviews those medications which are available for treatment of obesity, including many of those recently taken off the market. It also discusses some of the newer treatments that are currently being investigated. © 2011 Mariela Glandt and Itamar Raz.
Jirasevijinda T.,New York Medical College |
Brown L.C.,Bronx Lebanon Hospital Center
Patient Education and Counseling | Year: 2010
Objective: Medical educators have used Jeopardy!© game to teach medical knowledge. None has reported using it to teach psychosocial aspects of medicine. Methods: As part of a cross-cultural communication curriculum for residents in an urban, medically underserved area, we piloted " Bronx Jeopardy!©" to teach psychosocial aspects of the surrounding community. We applied the same rules used in the popular game show. Participants were asked to complete a survey to rate the content and format of the training. Results: Thirty-four residents participated; 30 (88%) completed the survey. Most reported that the information was new. Almost all reported increased understanding of community diversity, desire to learn more about it, and raised awareness of its challenges and resources. All believed that the session helped dispel negative stereotypes. Regarding format, all participants reported that it built collegiality, stimulated interest, was a fun and effective way to learn, and helped retain information. Conclusion: Bronx Jeopardy!© was a fun and effective way to learn about psychosocial aspects of pediatrics. Practice implications: Using a gaming format, Bronx Jeopardy!© demonstrated an application of Adult Learning Theory. With an expanding questions bank, the tool can be adapted for teaching this topic in other residency programs. © 2010 Elsevier Ireland Ltd.
Johnson B.,Bronx Lebanon Hospital Center
Journal of Pediatric Health Care | Year: 2014
Neonatal lupus (NL) is defined by the presentation of the fetus and the newborn who possess autoantibodies received from the mother. It is the dysfunction of the maternal immune system that leads to the production of autoantibodies to anti-Sjögren syndrome-A, anti-Sjögren syndrome-B, and anti-ribonuclear protein antigens. These antibodies are shared through the placenta and produce bodily changes in the fetal skin and heart, as well as potential changes in other body systems. Congenital complete heart block is the most dangerous manifestation of NL that can occur in utero or after birth. This article will provide an overview the presentation of NL and current therapies. Prenatal steroids have been the mainstay of therapy to try to reverse first- and second-degree congenital heart block and to prevent progression to a more advanced stage. New therapies are combining steroids with intravenous immunoglobulin and plasmapheresis. This article will provide guidelines for practitioners so they can consider NL as a differential diagnosis when presented with cutaneous lesions, congenital heart block, or abnormal findings in the hematologic, hepatobiliary, neurologic, and musculoskeletal systems. © 2014 National Association of Pediatric Nurse Practitioners.
Blitz N.M.,Bronx Lebanon Hospital Center
Clinics in Podiatric Medicine and Surgery | Year: 2010
Surgical reconstruction of symptomatic flatfoot associated with middle facet tarsal coalition is becoming more widely used. This article demonstrates that coalition-concomitant flatfoot is a pathologic entity that is worthy of surgical management. The literature, although limited, has suggested that poor outcomes with isolated simple coalition resection may have been related to the preoperative pes planus that was not addressed. More recently studies have demonstrated improved clinical and radiographic postoperative outcomes when the flatfoot correction is combined with the coalition resection. This article reviews a surgical treatment algorithm that considers the presence of varying degrees of pes planus and rearfoot arthrosis associated with coalition. © 2010 Elsevier Inc. All rights reserved.