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Project Journal Article - University of Pittsburgh

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									 THE DESIGN OF A THREE-SEGMENT THORACIC LUMBAR
             SACRAL ORTHOTIC BRACE



                DAVID K. HOWER: HIGH SCHOOL DIPLOMA
                                222 MELWOOD ST.
                                APARTMENT 501
                                PITTSBURGH PA, 15213
                                (724)-640-5722
                                DKH3@PITT.EDU

            ANJANI K. RAVINDRA: HIGH SCHOOL DIPLOMA
                                691 OSAGE RD.
                                PITTSBURGH PA, 15243
                                (412)-427-1493
                                RAVINDRA@PITT.EDU

            JESSICA A. SCHABERL: HIGH SCHOOL DIPLOMA
                                 400 OAK HILL DR.
                                 APARTMENT 415
                                 PITTSBURGH PA, 15213
                                 (814)-594-4359
                                 JAS72@PITT.EDU

           KIMBERLY ZAWROTNY: HIGH SCHOOL DIPLOMA
                              5826 FIFTH AVE.
                              APARTMENT 3-10
                              PITTSBURGH PA, 15232
                              (732)-814-3257
                              KAZ6@PITT.EDU


ACKNOWLEDGMENTS: MARK GARTNER, PHD – UNIVERSITY OF PITTSBURGH
                 ROBERT MAWHINNEY, CO – HANGER PROSTHETICS &
                      ORTHOTICS, INC.
                 MICHEAL BONINGER, MD – UNIVERSITY OF PITTSBURGH
                      PHYSICIANS
                 PRADEEP FULAY, PHD – UNIVERSITY OF PITTSBURGH




                                        1
           THE DESIGN OF A THREE-SEGMENT THORACIC LUMBAR
                       SACRAL ORTHOTIC BRACE

                         David Hower                                                     Anjani Ravindra
                      Jessica A. Schaberl                                               Kimberly Zawrotny


ABSTRACT                                                               and surgery, there are some difficulties associated with its use.
                                                                       The major problem with the TLSO brace is that it must be put
      Thoraco Lumbar Sacral Orthotic (TLSO) braces are used            on while the patient is lying down, which is difficult and time
to immobilize the spine following injuries or surgical                 consuming. Currently, placing the brace involves “log rolling”
procedures. Current bi-valve brace designs are difficult to            the patient onto their side and then positioning the back half of
place, which often leads to improper placement procedures and          the brace by sliding the side of it under the patient. This step is
ill fit. A Three-Segment TLSO brace was designed to counter            the most difficult part of placing the brace; one nurse may
these problems while providing the same level of support. A            struggle to perform this step alone, and it is nearly impossible
prototype was constructed, and verified with orthotics specialist      for a patient to do it themselves. After this step is completed
and self-placement tests. The results indicate that the Three-         the patient must be rolled back into their original position to
Segment brace was faster to place, with less required                  secure the brace and check if it is aligned correctly. If not, the
movement than the bi-valve design. The design was further              patient must again be rolled to readjust the brace. When the
validated by approval from orthotics and rehabilitation                back of the brace is in place, the front piece is placed on the
specialists. In conclusion, the Three-Segment brace offers a           abdomen and strapped onto the patient3. Throughout this entire
viable alternative to current bi-valve designs.                        procedure, the patient must be prevented from twisting or
                                                                       bending. Oftentimes, to avoid this lengthy and potentially
INTRODUCTION                                                           painful process, nurses will sit patients up to put on the brace.
                                                                       Patients who live alone are also encouraged to put the brace on
          Back braces are external devices utilized to support the     sitting up. Unfortunately, sitting up detracts from the intended
muscular and bony structures of the spine. While early braces          function of the brace since the spinal cord is already
were made of a heavy plaster, today’s braces are plastic and           experiencing a load due to gravitational effects before the brace
lighter weight for increased patient comfort and convenience1.         is placed.
Improving the comfort of braces has been shown to improve                        Solving the problem of correct brace placement will
patient compliance with brace use. Thus, there has been a trend        increase the patient’s ability to a have a safe recovery with
towards improving brace designs to increase comfort and ease           minimal pain. By decreasing the period of time that it takes to
of use. This paper will present a redesign of a thoracic lumbar        become mobile and correctly protected from further injury, the
sacral orthotic (TLSO) brace for this purpose.                         quality of life of patients that are recovering from spinal
          Many patients require the use of a TLSO brace to fully       procedures will be improved.
recover from either a spinal injury such as compression or burst                 This paper describes an attempt to improve the ease
fractures, or surgical procedures such as spinal fusions,              and speed of correct brace placement of a TLSO brace via a
decompressions, and treatment for ankylosing spondylitis2.             new brace design. We hypothesize that this new TLSO brace
The TLSO brace completely surrounds the torso and inhibits all         design will reduce the amount of rolling required for proper
bending and twisting of the upper body. Proper use of the              brace positioning. We further hypothesize that this brace
TLSO brace can help the spinal cord heal in an acceptable              design will allow for faster positioning of the TLSO brace over
amount of time. Without using the brace, the patient must              the current bi-valve braces. The new TLSO brace will have
remain in bed with very limited mobility and no applied                one front piece with two smaller side segments connected to the
pressure to the spine.                                                 sides of the front piece by hinges. The two side segments will
          There are many different designs for the TLSO brace.         then be connected to each other behind the patient by three
The design that is currently most commonly used is a two-piece         Dacron straps. Flexible material at the hinge sites will also be
brace, or bi-valve brace, that consists of a front half and a back     included, to avoid pinching the patient during the application
half (Figure 1a). The two halves are relatively similar in             process.
shape; they are both flat in the center and then curve to fit                    With this new design, the front piece would be
around the patient’s sides, much like a “U”. Since the sides of        correctly positioned on the patient first. The patient would then
the front half overlap with the sides of the back half, the patient    partially “log roll” onto their side so that one side segment
is forced to put the back half on first, followed by the front half.   could be placed down over the open side of the patient. The
The two halves are then tightened around the patient by three          patient could then roll onto their back again and keep going
adjustable Velcro straps on each side of the brace.                    onto their other side so that the other side segment could be
          While the TLSO brace described above can be of               placed down onto the patient. The brace would then be
significant benefit to patients recovering from spinal injuries        connected with the Dacron straps. The patient would now have


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the TLSO brace correctly placed around their torso in a timely
manner, with minimal rolling.
          The Three-Segment brace design allows for faster
brace placement without compromising either efficiency or
functionality. This method also does not require as much
maneuvering of the patient, since a full singular piece no longer
needs to be placed under the patient. Further, the redesigned
TLSO brace may help the hospital staff by decreasing the
difficulties they have with correct brace placement.

MATERIALS AND METHODS

Design Development:
          In the preceding section the need for improving the
ease and speed of correct TLSO brace placement were detailed.
At the onset of this project, several possible means of
addressing this need were considered. These included a variety
of assist devices that would aid in the proper placement of a
common bi-valve TLSO brace, as well as new materials or new
designs for the TLSO brace itself. Clinicians and orthotics
specialists were consulted to determine which of these ideas
would best improve the ease of correct brace placement,
without compromising the function of the brace or risking
further injury to the patient. From this consultation, it was
decided that the ideal solution to the TLSO placement problem
was a newly designed TLSO brace.
          The design chosen for the new TLSO brace is similar
to the bi-valve TLSO brace, with several key features which
will improve the ease of brace placement. In order to reduce
                                                                          Figure 1a: Commonly used bi-valve TLSO brace design.
the amount of “log rolling” required by the patient during
placement, the back segment of the TLSO brace is divided into
two side segments. Since the side segments are being placed
on the patient’s exposed side, there is no need to force the brace
underneath the patient, and thus pain is decreased. Splitting the
back of the brace does not compromise the brace function,
because the bulk of support and motion restriction is provided
by the front piece of the brace.
          Another key feature of the Three-Segment TLSO
brace is permanent attachment of the segments. Bi-valve
TLSO braces consist of two separated pieces which must be
handled separately.       This makes the brace awkward to
manipulate, because both pieces need to be held in place and
moved with relation to one another.               To reduce the
awkwardness of handling several brace pieces at once, the side
segments will be attached to the front piece via metal hinges.
This design concept is illustrated in Figure 1b. A patent search
was performed to ensure that the proposed three-segment
TLSO brace is a unique concept. Though similar designs are
currently being used for the treatment of kyphosis or high
thoracic scoliosis, no variation of this design is currently being
used for spinal injury or surgery.
          Using this initial design concept, a detailed description
of the brace requirements was formulated. Consideration was
given to size restrictions, safety hazards, performance
requirements, and operating conditions4. Potential hazards and
risks were then identified. The bulk of these hazards, such as
improper placement or the connection of the brace, are related
to human error and will be accounted for with detailed written
instructions for the patient and warning labels fixed to the brace
itself5. Several hazards elicited design adjustments, such as the           Figure 1b: Three-Segment TLSO Brace prototype.
inclusion of flexible overlaps between the patient’s skin and the



                                                                      3
                                                                     TLSO brace is easier for patients and hospital staff to put on
                                                                     correctly.
hinges of the brace to prevent skin pinching when the side                     First, timed trials will be conducted utilizing Hanger
segments are moving5.                                                Orthotics’ facilities. A Hanger employee, experienced in
                                                                     putting on TLSO braces, will be timed while placing a
Prototype Fabrication:                                               traditional bi-valve brace on the subject. Then, the process will
          Upon completion of the design requirements, the            be repeated with the Three-Segment brace. Each brace will be
design for the initial Three-Segment TLSO brace prototype was        placed three times, and the average time of the trials will be
presented to Hanger Prosthetics & Orthopedics, Inc. Hanger           compared to determine whether or not an improvement in speed
Orthopedic agreed to provide a prototype of the initial design.      was seen with the Three-Segment brace.
          A test subject was selected randomly from amongst                    A second time test will compare the time it takes to
the authors, and a mold of the subject’s torso was made. A           put the bi-valve brace on oneself versus the three-segment
cotton body sock was used to protect the subject’s skin and          brace. The subject will attempt to place the bi-valve TLSO
clothing during the procedure. An indelible ink pencil was           brace while in the proper supine position. The test will be
used to mark the indentations of the hip bones. Then, the            repeated using the Three-Segment TLSO brace. Each brace
subject was wrapped in 4 inch plaster bandages (SPS,                 design will be placed three times, and the average time of the
Alpharetta GA). This negative mold was allowed to solidify,          three trials will be compared between the two brace designs.
and then was cut along the side with a cast saw.                               A third test will quantify the amount of rolling
          The negative mold was removed from the subject, and        required to properly position the Three-Segment TLSO brace,
converted to a positive mold by filling it with molding plaster.     as compared to the bi-valve brace. During the self-placement
The inside of the negative mold was lined with soap in order to      time trial described above, the number of times the subject
prevent the plaster from sticking. The positive mold was             needs to log roll in order to position the brace will be recorded
allowed to solidify, and then was smoothed as needed with            for each test of each brace. A full log roll will be considered a
sandpaper. 4-E Volar Foam lining (SPS, Alpharetta GA) was            motion that brings the subject entirely onto one side. A half log
heat molded to the positive mold in an oven (Grieve Co.,             roll will be considered a motion that only involves partial
Round Lake IL). Next, a vacuum former (Speedaire, Tukwila            shifting of weight onto one side. The average number of log
WA) was used to vacuum fold prosthetic grade Copolymer               rolls required to put on each brace across the three trials will be
plastic (AIN plastic, Madison Heights MI) around the lining.         compared.
Plastic cutters were then used to trim the prototype to the
proper dimensions.          4 inch strap hinges (Brainerd            RESULTS
Manufacturing Co., East Rochester NY) were added between
the front and side segments. A portion of cotton body sock was            The results of the orthotics specialist test can be found in
glued between the foam and plastic layers of the brace behind        Table 1. Table 2 summarizes the results of the self-placement
the hinges. Three 1 inch Dacron Strap webbing and hinges             test. Table 3 summarizes the results of the rolling test. The
(SPS, Alpharetta GA) were added to the side segments of the          average time required for the Hanger employee to place the bi-
brace.                                                               valve brace was 89 seconds. The average time required for him
          The materials chosen for the brace were selected for       to place the Three-Segment brace was 45 seconds. The average
durability and hypoallergenic properties. They also comply           time for placement of the bi-valve brace was 117 seconds, with
with standards for prosthetic materials, and are commonly used       2.8 log rolls required. The average time for placement of the
by Hanger Orthopedic for the creation of bi-valve TLSO               Three-Segment brace was 99 seconds, with 1.5 log rolls
braces. Dacron straps were used instead of Velcro straps,            required.
which are commonly used on bi-valve braces. The Dacron                          Table 1: Orthotics Specialist Test Results
straps allow for easier manipulation and tightening of the brace              Brace Type               Trial Time (sec)
on the user.                                                                                            1            83
          After the creation of the first prototype, the brace was
placed on the subject to test fit and function. Several design                Bi-Valve                  2            105
changes were considered from this initial testing, including the                                        3             80
incorporation of a plastic overlap between the two side                                                 1             40
segments of the brace. It was thought that this overlap would                 Three-Segment             2             45
avoid pinching of skin or clothing during tightening of the
                                                                                                        3             50
brace. However, after adding an overlap, it was determined to
be a hindrance to easy placement procedure. Consultation with
                                                                                 Table 2: Self-Placement Test Results
Hanger Orthopedic lead to the decision to remove the overlap,
as pinching is rarely a problem in posterior-closing scoliosis               Brace Type             Trial Time (sec)
braces.                                                                                              1          130
                                                                             Bi-Valve                2          111
Testing Procedures:                                                                                  3          109
          A series of tests have been developed to analyze the
                                                                                                     1          103
performance of the newly designed TLSO brace. Specifically,
these tests seek to determine whether or not the Three-Segment               Three-Segment           2           99
                                                                                                     3           95



                                                                     4
                                                                      rolling not only increases the speed of placement, but also
                Table 3: Rolling Test Results                         decreases pain to the patient. Thus, the Three-Segment brace
       Brace Type             Trial Rolls Required                    uses a placement procedure that is less likely to hurt the patient,
                               1            3.5                       and so is more likely to be followed.
                                                                                In order to further support the hypotheses, additional
       Bi-Valve                2            2.5                       environmental and clinical testing may be required. However,
                               3            2.5                       current results indicate that the Three-Segment TLSO offers a
                               1            1.5                       viable alternative to the traditional bi-valve designs.
       Three-Segment           2            1.5
                               3            1.5                       REFERENCES

DISCUSSION                                                            1. Spinal Braces [Scoliosis Associates web site]. Available at:
                                                                         http://www.scoliosisassociates.com/subject.php?pn=braces-
          The results indicate that the Three-Segment TLSO               036. Accessed December 13, 2006.
brace can be placed faster than the bi-valve brace. This was
true in the orthotics specialist test as well as the self-placement   2. Shaffrey, Christopher. Ankylosing Spondylitis: Treatment
test. It is especially significant that the Orthotics Specialist,        and Recovery. February 15, 2007. Available at:
with 25 years of experience placing bi-valve braces, was able to         http://www.spineuniverse.com/displayarticle.php/article1008.
place the Three-Segment brace in half the time. The faster               html. Accessed April 17, 2007.
times indicate that the Three-Segment TLSO brace is more
easily placed than a bi-valve brace, for both healthcare              3. Pashman, RS. Bracing for Scoliosis. September 9, 2006.
professionals and patients.                                              Available at: http://www.espine.com/Bracing.htm. Accessed
          Further, the self-placement test demonstrates that less        December 13, 2006.
rolling is required to place the Three-Segment TLSO brace.
This is because the Three-Segment brace can be positioned             4. Initial Hazard Analysis Rev. 20. Dave Hower, Anjani
correctly on the front before any rolling takes place. This              Ravindra, Jessica Schaberl, and Kimberly Zawrotny. Three
reduces the need for the readjustment rolling frequently needed          Segment TLSO Brace Design History File. 12/15/2006.
with bi-valve TLSO braces.
          The results of the two studies of the Three-Segment         5. Product Design Specifications Rev. 1.0. Dave Hower,
TLSO brace were used to validate the design. After reviewing             Anjani Ravindra, Jessica Schaberl, and Kimberly Zawrotny.
the reduction in time and rolling associated with the Three-             Three Segment TLSO Brace Design History File.
Segment brace, both rehabilitation and orthotics specialists             12/15/2006.
approved the design. Both professionals claimed to feel
comfortable in prescribing the new design to patients with back
injuries.
          While beyond the scope of this study, further testing
should be done to show that the Three-Segment TLSO brace
can be incorporated into the same environments as the bi-valve
design. Specifically, the braces should be tested in a variety of
ambient temperatures and humidity levels.                Effects of
submersion and contact with various fluids on the brace
materials should also be tested. These trials will prove that the
Three-Segment TLSO brace will function under the same
operating conditions as the bi-valve brace.
          Clinical testing with spinal surgery or injury patients
would also be needed. Patients and hospital staff could
compare the ease of putting on both bi-valve and Three-
Segment braces. A survey could be used to analyze preferences
for each feature of the brace, and adjustments to the design
could be made accordingly.

CONCLUSION

         It was hypothesized that the Three-Segment TLSO
brace would allow for a faster, simpler placement procedure.
The testing thus far has shown that the Three-Segment brace
can be placed faster than a bi-valve brace by both test subjects
and orthotics specialists. The faster time indicates an easier
placement process for the Three-Segment brace. The testing
has also demonstrated that less rolling is required for placement
of the Three-Segment brace. The reduction in readjustment


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