FACULTY SPONSOR�S NAME AND DEGREE: by HC111207122354

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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: heary@umdnj.edu
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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