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Transcript of The Effectiveness of Cervical Spine Orthoses at Restricting Spinal Movement: A 3-D Motion Analysis...
146S Proceedings of the NASS 26th Annual Meeting / The Spine Journal 11 (2011) 1S–173S
the posterior lumbar instrumentation using a pedicle screw by a single sur-
geon; and intraoperatively had an insertion torque of pedicle screw mea-
sured by digital torque gauge. Conventional 6.5 mm diameter by 40 to
45 mm length self-tapping pedicle screw was placed.
OUTCOME MEASURES: In regard to the maximal insertion torque, an
analysis was performed using Pearson’s correlation coefficient for the
BMD at the corresponding surgical vertebrae, mean BMD at the lumbar
vertebrae and mean BMD in the proximal femur.
METHODS: A simple regression analysis was also performed to evaluate
the correlation between the BMD and the predicted insertion torque gen-
erated during a pedicle screw fixation. Besides, based on the mean BMD
in the lumbar vertebrae, patients were classified into the normal group
(T-value O�1.0), the osteopenia group (�2.5!T-value #�1.0) and the
osteoporosis group (T-value #�2.5).
RESULTS: In regard to the insertion torque during a pedicle screw fixation,
there was a positive correlations with the BMD at the surgical vertebrae
(r50.49), T-value at the surgical vertebrae (r50.52), mean BMD in the lum-
bar vertebrae (r50.32), mean T-value in the lumbar vertebrae (r50.50),
mean BMD in the proximal femur (r50.45) and mean T-value in the prox-
imal femur (r50.42). In patients with osteoporosis, the insertion torque had
positive correlations with the BMD at the surgical vertebrae, T-value at the
surgical vertebrae and mean BMD in the lumbar vertebrae. In patients with
osteopenia, the insertion torque had weak positive correlations with the
BMD at the surgical vertebrae, T-value at the surgical vertebrae, mean
T-value in the lumbar vertebrae, meanBMD in the proximal femur andmean
T-value in the proximal femur. The insertion torque was significantly lower
in patients with osteoporosis and those with osteopenia as compared with
normal patients. Besides, a regression analysis formula for the insertion
torque (kgf$cm) was found to be�1.3þ16.1 X (the BMD at the surgical ver-
tebrae), 9.6þ7.87 X (mean BMD in the lumbar vertebrae) and �3.26þ24.6
X (mean BMD in the proximal femur).
CONCLUSIONS: The insertion torque generated during a pedicle screw
fixation had positive correlations with the BMD at the surgical vertebrae,
mean BMD in the lumbar vertebrae and mean BMD in the proximal femur.
Particularly in patients with osteoporosis and normal patients, this correla-
tion was more notable as compared with patients with osteopenia. But
there was no significant correlation with the internal diameter of a pedicle
at the surgical sites. Besides, a variable degree of torque was observed dur-
ing a pedicle screw fixation even at the same degree of BMD. The BMD
therefore be used in predicting the accurate degree of a pedicle screw fix-
ation. Because there is a positive correlation between the BMD and the fix-
ation force of a pedicle screw, however, it can therefore be inferred that the
assessment of BMD would be useful in determining the fixation of device
and the number of fusion segments in patients who are suspected to have
osteoporosis and indicated in a pedicle screw fixation.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.352
P51. Physical Therapy Intervention for Specific Spinal Pathologies:
Which Patients Experience the Greatest Improvement?
Daniel Mulconrey, MD, Patrick O’Leary, MD; Midwest Orthopaedic
Center, Peoria, IL, USA
BACKGROUND CONTEXT: No previous study has evaluated physical
therapy protocols to determine if a particular spinal diagnosis demonstrates
greater benefit from therapy intervention. This study is designed to deter-
mine the role of physical therapy for patients with spine disease.
PURPOSE: Examine the efficacy of therapy for specific lumbar spine pa-
thologies. In addition, to highlight discrepancies or similarities among
these patient groups.
STUDY DESIGN/SETTING: Retrospective case review to evaluate the
benefit of a physical therapy (PT) protocol for patients with spinal
pathology.
All referenced figures and tables will be available at the Annual Mee
PATIENT SAMPLE: 1300 patient charts were retrospectively reviewed
from an outpatient therapy clinic from 2009-2011. Patients with a diagnosis
of lumbar based pain(LBP), radiculopathy (RD), or spinal steonsis (SS)
were included. Inclusion criteria wereO18yrs age, no previous spinal sur-
gery, and completion of PT course.
OUTCOME MEASURES: Pre-therapy and post-therapy Oswerstry Dis-
ability Index (ODI) and Visual Analog Pain Scale (VAS) were assessed in
the retrospective review. In addition, any discrepancy or alteration in the
treatment plan would be evaluated. Failure to complete the treatment plan
would exclude the patient from this study.
METHODS: 147 patients met the inclusion criteria. Pre-therapy and post-
therapy Oswerstry Disability Index (ODI) and Visual Analog Scale (VAS)
were recorded. Total visits until therapy goals accomplished, appointment
cancellations, and comorbidities (CAD, COPD, etc) were documented.
Therapy interventions included exercise program, manual therapy, aquatic
therapy, and modalities.
RESULTS: Mean age (54.0 yrs LBP, 52.9 RD, 69.9 SS) and presence of co-
morbidities (77.3% LBP, 69.2% RD, 90.9% SS) were similar in LBP and
RD, but differed in SS (p!.01). Mean total visits were similar (12.3 LBP,
13.1 RD, 14.8 SS). Mean pre-therapy ODI and VAS did not statistically dif-
fer among groups (LBP 42.0, RD 46.4, SS ODI 43.4) (LBPVAS 6.3, RD 5.4,
SS 8.0). Mean post-therapy SS ODI (26.7) was statistically higher (LBP
16.3, RD 17.9, p!.01). Mean post therapy VAS was similar (LBP VAS
1.55, RD 1.84, SS 2.93). Mean change in ODI was greatest in RD (DODI
28.5) and LBP (D25.6) (SS DODI 16.7, p!.01) Mean change in VAS was
similar (LBPDVAS 4.7, RD D3.6, SS D 5.1). Patients with comorbidities
demonstrated similar mean pre-therapy ODI (43.1 vs 44.3) and improve-
ment in pain scores. (DODI 23.7 vs 25.7 and DVAS 4.76 vs 3.7).
CONCLUSIONS: Patients referred to physical therapy for spinal disease
demonstrate improvement through the course of treatment. Medical co-
morbidities do not appear to be a negative confounding variable for ther-
apy intervention. Spinal stenosis patients demonstrate a higher level of
comorbidities, less improvement in ODI, and maintain a higher level of
disability post-therapy. Patients with lumbar based pain and radiculopathy
obtain similar improvement with physical therapy. Physical therapy proto-
cols demonstrate significant reduction in disability and pain in all patients
with spinal disease and should continue to be included in the non-operative
management of spinal pathology.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.353
P52. The Effectiveness of Cervical Spine Orthoses at Restricting
Spinal Movement: A 3-D Motion Analysis Study
Nicholas Evans, MD; Winchester, UK
BACKGROUND CONTEXT: Assessing the effectiveness of cervical or-
thoses at restricting spinal motion has historically proved challenging due
to a relatively poor understanding of spinal kinematics and the technolog-
ical limitations of accurately measuring spinal motion.
PURPOSE: This study is the first to use an 8-camera optoelectronic pas-
sive marker motion analysis system in conjunction with a novel marker
placement design to compare the effectiveness of the Aspen, Aspen Vista,
Philadelphia, Miami-J and Miami-J Advanced collars at restricting cervical
spine motion through physiological and functional ranges.
STUDY DESIGN/SETTING: Experimental study design. Uncollared sub-
jects acted as their own controls. The order in which collars were assessed
was decided through double blind random selection. Physiological ranges
of movement were defined as the maximal active movements permissible
in the sagittal, transverse and coronal planes. Functional ranges of movement
were assessed as the subjects performed five activities of daily living (ADLs).
PATIENT SAMPLE: Nineteen healthy volunteers (12 female, 7 male)
aged between 18 and 38 years were recruited to the study. Subjects had
no known history of spinal injury and no previous spinal pathology.
ting and will be included with the post-meeting online content.
147SProceedings of the NASS 26th Annual Meeting / The Spine Journal 11 (2011) 1S–173S
OUTCOME MEASURES: The range of movement and % restriction to
movement were used as outcome measures.
METHODS: Collars were fitted by an approved physiotherapist. Eight
ProReflex (Qualisys, Sweden) infra-red cameras were used to track the
movement of retro reflective marker clusters placed in predetermined po-
sitions on the head and trunk. 3-D kinematic data was collected during for-
ward flexion, extension, lateral bending, axial rotation and during the
ADLs from uncollared and collared subjects. The range of motion in the
three planes was analysed using the Qualisys Track Manager system.
RESULTS: Through physiological ranges, the Aspen and Philadelphia col-
lars were significantlymore effective at restricting flexion/extension than the
Vista (p!.001), Miami-J (p!.001 and p!.01) and Miami-J Advanced
(p!.01 and p!.05) collars. The Aspen collar was significantly more effec-
tive at restricting axial rotation than the Vista (p!.001) and the Miami-J
(p!.05) collars. The Aspen, Philadelphia, Miami-J and Miami-J Advanced
collars were comparable at restricting lateral bending but the Vista was the
least effective collar at restricting movement in this plane (p!.001).
Through functional ranges, the Vista collar was significantly less effective
than the Aspen (p!.001) and other collars (p!.01) at restricting flexion/ex-
tension. The Aspen and Miami-J Advanced collars were significantly
more effective at restricting rotation than the Vista (p!.01 and p!.05) and
Miami-J (p!.05) collars. All the collars were comparable at restricting lat-
eral bending.
CONCLUSIONS: The Aspen is superior and the Aspen Vista inferior to
the other collars at restricting cervical spine motion through physiological
ranges. Functional ranges of motion observed during activities of daily liv-
ing are less than those observed through physiological ranges. The Aspen
Vista is inferior to the other collars at restricting motion through functional
ranges. The Aspen collar again performs well, particularly at restricting ro-
tation, but is otherwise comparable to the other collars at restricting motion
through functional ranges.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.354
P53. Innovative Bone Void Filler Putty Based on Recombinant
Human Type-I Collagen for Spinal Bone Repair
Shani Shilo, PhD, Racheli Gueta, PhD, Tamar Harel-Adar, PhD,
Sigal Roth, Or Dgany, PhD, Oded Shoseyov, PhD, Hagit Amitai, PhD,
MBA; Collplant, Ness Ziona, Isreal
BACKGROUND CONTEXT: When applied as a scaffolding component,
Type-I collagen is both biocompatible and provides for cell conductivity.
Moreover, ceramic-collagen bone substitute composites most closely re-
semble autografts, the gold standard of spinal repair materials. To date, an-
imal and cadaveric tissues comprise the primary sources of commercially
available collagens, bearing health risks in the form of pathogens, immuno-
gens and allergens. Use of a plant-derived, recombinant human collagen as
a robust source of collagen could offer a safer, superior alternative to animal
and cadaver-derived collagen. Upon its formulation into putty, effective os-
teoconductive malleable collagen scaffolds can be inserted into spinal bone
defects.
PURPOSE: To engineer and test the bone filler performance of malleable
putty formulations of recombinant Type-I collagen derived from engi-
neered tobacco plants.
STUDY DESIGN/SETTING: Malleable putty was fabricated from re-
combinant human Type-I collagen and ceramics and its bone void filler
performance was evaluated both in vitro and in vivo.
METHODS: Tobacco plants were genetically engineered to express five
human genes (Collagen-I a1, Collagen-I a2, P4H-a, P4H-b and LH3) es-
sential for the production of functionally stable human Type-I collagen.
Comparative biochemical and molecular biology assays including amino
acid sequencing, circular dichroism spectroscopy, high-resolution electron
All referenced figures and tables will be available at the Annual Mee
microscopy, SDS-PAGE, GP-HPLC, ELISA-based affinity testing, and
sensitivity to collagenase, characterized the resultant recombinant human
collagen with respect to native human collagen. Putty-like collagen-
ceramic scaffolds were fabricated and their performance was evaluated
in a rabbit tibia defect model and in an in vitro osteoblast proliferation
assay.
RESULTS: For the first time, successful mass production of recombinant
human Type-I collagen was achieved. Biochemical and physical character-
ization of the protein’s amino acid sequence and composition, structure
and organization, molecular weight, affinity to collagen-specific anti-
bodies, resistance to non-specific proteases and susceptibility to collage-
nase confirmed its identity to Type-I human collagen. The purified
recombinant collagen assembled into fibrils and formed hydrogels, respec-
tively featuring D-banding and a 3-D structure typical of collagen. Bone
void filler scaffolds fabricated from recombinant collagen and ceramic
were highly porous and a formed cohesive putty upon hydration and
kneading. When applied to a critical-size rabbit tibia defect model, the re-
combinant human collagen putty remained stably affixed under both bleed-
ing and saline irrigation conditions. In addition, the recombinant human
collagen-based putty scaffold allowed for enhanced proliferation of pri-
mary human osteoblasts when compared to commercially available demin-
eralized bone.
CONCLUSIONS: The innovative putty-like bone void filler formed of re-
combinant Type-I human collagen expressed in and purified from trans-
genic plants, demonstrates cohesive and malleable properties, rendering
it appropriate for spinal bone repair applications. Moreover, its efficacy
in promoting osteoblast cell proliferation may foster clinical outcomes.
When mixed with bone marrow aspirate, the collagen-ceramic putty is ex-
pected to enable binding and controlled release of natural bone growth fac-
tors.FDA device status: The VergenixBVF recombinant human collagen
type-I putty bone void filler is currently under development.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.355
P54. Bone Scan in Osteoporotic Vertebral Compression Fracture
Patients
Chang Hun Yu, MD1, Deuk Soo Jeon, MD, PhD2, Dong Hwan Kim, MD2;1Gacheon Medical Center, Incheon, South Korea; 2Gil Medical Center,
Gacheon Medical University, InCheon, South Korea
BACKGROUND CONTEXT: The back pain caused by osteoporotic ver-
tebral compression fracture (OVCF) can be effectively treated using verte-
broplasty or balloon kyphoplasty. However, many patients with OVCF
complain of chest pain and some patients show no satisfactory improve-
ment of pain after vertebroplasty, or continuous chest pain even after ver-
tebroplasty. There have been controversies over the causative factors and
the authors noted simultaneous rib fracture as a hypothetical cause of this
phenomenon. In addition, the early diagnosis of osteoporotic compression
fracture and the detection of the concomitant fracture of vertebral body at
nonadjacent sites are difficult and missed in many cases.
PURPOSE: The purpose of this study was to investigate the incidence and
risk factors of simultaneous rib fracture in the patients with OVCF using
bone scan. We also evaluated the incidence of concurrent fracture of non-
adjacent vertebral body and feasibility of bone scan as a screening test for
uncertain compression fracture.
STUDY DESIGN/SETTING: Prospective study on the feasibility of bone
scan for the patients with osteoporotic vertebral compression fracture.
PATIENT SAMPLE: Three hundred sixty nine patients underwent verte-
broplasty or balloon kyphoplasty and 284 patients among them were en-
rolled in this study.
OUTCOME MEASURES: Frequency of hot spots in ribs on bone scan,
frequency of cases with missed diagnosis of multiple fractures using
ting and will be included with the post-meeting online content.