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.