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Summer Student Research Program Project Description FACULTY SPONSOR’S NAME AND DEGREE: Robert Heary, M.D. PHONE: (973) -972 - 2334 DEPARTMENT AND INTERNAL MAILING ADDRESS: DOC Suite 8100, 90 bergen street, Newark NJ, 07103 E-MAIL: email@example.com PROJECT TITLE (200 Characters max): IN VITRO ASSESSMENT OF THE EFFECT OF ANNULAR RESECTION ON THE FSU EXPULSION FORCE, MIGRATION, RANGE OF MOTION, AND WEAR PROPERTIES FOR AN ARTIFICIAL DISC HYPOTHESIS: The proposed study is not a hypothesis-based study. A major concern of artificial disk replacement is that of implant migration. U.S. policy mandates that this class of devices be tested rigorously before they are marketed. At present in the United States several artificial disks are undergoing testing in humans. For our study, we are trying to provide evidence for the use of artificial disc. PROJECT DESCRIPTION (Include design, methodology, data collection, techniques, data analysis to be employed and evaluation and interpretation methodology) Design: The proposed study is an in vitro study designed to assess the effect of annular resection on the FSU expulsion force, migration, range of motion and wear properties for an artificial disc. Methodology: In order to study the effect of annular resection on the biomechanics of the artificial disc, 18 fresh cadaveric lumbar spines from L2-S1 will be dissected into two level motion segments (L2-L3, L4-L5, L3-L4 and L5-S1); hence 36 motion segments will be obtained. Each specimen will be mounted in gripping fixtures and tested intact for multiple cycles of non-destructive loading in compression followed by several cycles in flexion. An annulotomy will then be performed and the specimens will be tested again after implantation of the artificial disc. The vertebral range of motion for the implant will be compared against that of the intact spine segment. The degree of disc migration and bone-implant interface will also be analyzed. Data Collection: All specimens will undergo fluoroscopy before and after being loaded on the Enduratec machine, which is an endurance testing machine. The specimens will be compressed with a load of 500 N and a flexion moment of 10 Nm, at a rate of 2 Hz for 100,000 cycles. The load, displacement and stiffness of the specimens will be thus recorded. The range of motion will be measured using a motion tracking system, to study the changes in motion after varied percentages of annular resection. Annular resection will be performed with either 30% or 50% of the total annulus removed; and then the specimens will be tested biomechanically, similar to the intact specimen testing. Thus, the comparison between intact conditions and after implantation of the artificial disc will be assessed and the performance of the artificial disc will be analyzed. After the termination of all biomechanical measurements, each specimen will be sectioned/cut and the interface between the bone and the implant will be assessed microscopically using an image analysis system. For wear testing, a fixture matching the endplates of the artificial disc will be placed in a hyperlordotic posture and loaded for 1 million cycles and then the wear will be collected and the surfaces will be analyzed for wear orientation. Techniques: The technique will be used in this study are: 1. In vitro study. 2. Using of a fluoroscopy. 3. Data entry and spreadsheet. 4. Statistical package of SPSS. Summer Student Research Program Project Description Data Analysis: Statistical package SPSS for windows version 12.0 will be used and the independent T-testing statistical procedure will be the analysis method. Evaluation and interpretation: A major concern of artificial disk replacement is that of implant migration. U.S. policy mandates that this class of devices be tested rigorously before they are marketed . The study is an in vitro study designed to assess the use of artificial disc. Our study will provide evidence for the use of artificial disc in human being. SPONSOR’S MOST RECENT PUBLICATIONS RELEVANT TO THIS RESEARCH: 1. Heary RF, Kumar S: Treatment of civilian gunshot wounds of the spine. Techniques in Orthopaedics, 2006, in press. 2. Heary RF, Salas S, Bono CM, Kumar S: Complication avoidance: Thoracolumbar and lumbar burst fractures. Neurosurg Clin N Am 17:377-388, 2006. 3. Heary RF, Bono CM: Pedicle subtraction osteotomy in the treatment of chronic, posttraumatic kyphotic deformity. J Neurosurg Spine 5:1-8, July 2006. 4. Grant GP, Heary RF, Turbin RE: Measurement of table elevation of the Jackson spine table for studies involving the reverse Trendelenburg position. J Neurosurg Anesthesiol 18(2):161, April 2006. 5. Heary RF: Evaluation and treatment of adult spinal deformity. J Neurosurg (Spine 1) 1:9-18, 2004. IS THIS PROJECT SUPPORTED BY EXTRAMURAL FUNDS? Yes or No (IF YES, PLEASE SUPPLY THE GRANTING AGENCY’S NAME) THIS PROJECT IS: Clinical Laboratory Behavioral Other THIS PROJECT IS CANCER-RELATED THIS PROJECT IS HEART, LUNG & BLOOD- RELATED THIS PROJECT EMPLOYS RADIOISOTOPES THIS PROJECT INVOLVES THE USE OF ANIMALS PENDING APPROVED IACUC PROTOCOL # THIS PROJECT INVOLVES THE USE OF HUMAN SUBJECTS PENDING APPROVED IRB PROTOCOL # THIS PROJECT IS SUITABLE FOR: UNDERGRADUATE STUDENTS ENTERING FRESHMAN SOPHMORES ALL STUDENTS THIS PROJECT IS WORK-STUDY: Yes or No WHAT WILL THE STUDENT LEARN FROM THIS EXPERIENCE? Summer Student Research Program Project Description The summer student will learn to conduct in vitro study. to input data in a spreadsheet and to clean data for further analysis. to use of fluoroscopy.
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