70S Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S

cement itself influences biomechanically on the occurrence of AVF follow-

ing PVP. Especially, when injected cement form solid mass rather than in-

ter-digitation, the risk of upper adjacent fracture may increase.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi:10.1016/j.spinee.2008.06.163

134. Transforaminal Steroid Injections Delay Motor Recovery in

Patients with Acute Sciatica Secondary to Herniated Nucleus

Pulposus

Paul Bishop, DC, MD, PhD, Charles Fisher, MD, MSc, FRCS, Peter Wing,

MB ChB, MSc, FRCS, Marcel Dvorak, MD, FRCS; Combined

Neurosurgical & Orthopaedic Spine Program, Department of

Orthopaedics, University of British Columbia, Vancouver, British

Columbia, Canada

BACKGROUND CONTEXT: An image-guided transforaminal steroid

injection (TSI) has been demonstrated to reduce pain and obviate the need

for surgery in some patients with acute sciatica secondary to herniated disc

(AS/HD). However, the potential exists for steroid treatment to adversely

alter the natural history of the acute inflammatory response associated with

AS/HD.

PURPOSE: To determine if patients with AS/HD and an accompanying

motor deficit who receive standardized non-operative treatment (SNT)

and a TSI, have a different spinal nerve root motor score outcome when

compared with patients who received SNT without TSI.

STUDY DESIGN/ SETTING: A prospective observational two-arm co-

hort study.

PATIENT SAMPLE: Inclusion criteria: Ages 19–59 with AS/HD choos-

ing non-operative care. Motor score deficits of 3–4/5. Excluded: ‘‘Red

flag’’ conditions or prior history of sciatica / lumbar spine surgery.

OUTCOME MEASURES: Change in spinal nerve root motor score at

8,16 and 24 weeks post baseline assessment.

METHODS: All patients were evaluated using a standardized assessment

protocol. Motor function was scored out of 5 at baseline, 8,16 & 24 weeks.

Group A patients received a TSI within 2 weeks from baseline and SNT that

included non-narcotic analgesic medication, re-assurance, and re-activation

advice. Group B received the same treatment, but without a TSI. Ethics ap-

proval was obtained.

RESULTS: 61 patients were recruited with 31 in Group A and 30 in

Group B. Mean baseline motor scores were not significantly different in

Groups A and B. At 8 weeks post-baseline 58% of patients in Group A

and 76% in Group B had a 5/5 motor score at (p!0.01); at 16 weeks post

baseline, 65% of patients in Group A and 87% in Group B had a 5/5 motor

score (p!0.001) and at 24 weeks post baseline, 90% of patients in Group A

and 100% in group B had a 5/5 motor score. (p!0.005).

CONCLUSIONS: In the patient population studied, spinal nerve root mo-

tor score improvement was inhibited by the use of TSI in patients with AS/

HD.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi:10.1016/j.spinee.2008.06.164

135. Does An Adjacent Abnormal Non-Concordant Discogram

Impact the Clinical Results of Lumbar Artificial Disc Replacement

(ADR)?

Kenneth Pettine, MD, E. Jeffrey Donner, MD; Rocky Mountain Spine

Arthroplasty Specialists, Loveland, CO, USA

BACKGROUND CONTEXT: This is the only study performed to specif-

ically evaluate the question of whether ADR can be successfully performed

above or below disc’s that are abnormal on MRI and non-concordant in pain

response based on discography.

PURPOSE: To determine if it is safe and effective to perform ADR above

or below an abnormal non-concordant disc.

STUDY DESIGN/ SETTING: Every patient involved in FDA IDE stud-

ies with three different ADRs were evaluated at two-year follow-up for

clinical success and divided into two groups. Group A had a single abnor-

mal disc based on MRI and discograms with a normal disc above and/or

below. Group A included 28 patients. Group B had a single abnormal disc

with an adjacent abnormal, non-concordant disc above and/or below based

on discography. Group B included 18 patients.

PATIENT SAMPLE: Demographics between the groups in terms of gen-

der, BMI, levels operated upon, and type of ADR were similar. Specific

data will be discussed. The average age of Group A was 34.3 vs. the aver-

age age of Group B at 44.5. This difference was significant. Three types of

ADR were studied, the Charite (20 patients), the KineFlex (13 patients),

and the Maverick (13 patients).

OUTCOME MEASURES: Clinical success was based on the FDA IDE

study criteria and specifics will be discussed.

METHODS: Every patient in the study underwent pre-operative MRI

and discograms at L3-4, L4-5, and L5-S1. Discogram results were based

on the Dalles discogram classification. All patients underwent a single

level ADR based on abnormal MRI and abnormal concordant discogram.

All patients were then followed prospectively with a minimum two-year

follow-up.

RESULTS: Group A had a pre-op average oswestry of 60.8 and VAS of

76.4. Two-year follow-up oswestry averaged 29.4 and VAS of 41.8. Group

B had a pre-op average oswestry of 61.2 and VAS of 78.7. Two-year

follow-up oswestry averaged 16.9 and VAS of 17.8. IDE clinical success

averaged 86% in Group A and 88% in Group B. There was no difference

in complications or recovery time between the groups.

CONCLUSIONS: Group A and B were similar in all demographics ex-

cept age. The average age in group B was 10 years older than group A.

This group appears to demonstrate the natural aging process of non-

concordant annular tears. Their clinical results in terms of improvement

was actually better than Group A, but not statistically significant. These re-

sults indicate it is safe and effective to perform ADR above or below an

abnormal non-concordant disc. Clinical results can be expected to be sim-

ilar to the more ideal patient with a totally normal disc adjacent to ADR.

FDA DEVICE/DRUG STATUS: Maverick: Investigational/Not ap-

proved; Kineflex: Investigational/Not approved; Charite: Approved for this

indication.

doi:10.1016/j.spinee.2008.06.165

Friday, October 17, 20083:20–4:20 PM

Concurrent Session 1: Lumbar

136. Two Level ProDisc�-L IDE Clinical Trial vs. One Level

ProDisc�-L IDE Clinical Trial

Jeffrey Goldstein, MD1, Rick Delamarter, MD2, Jack Zigler, MD3,

Richard Balderston, MD4; 1NYU Hospital for Joint Diseases, New York, NY,

USA; 2Santa Monica, CA, USA; 3Plano, TX, USA; 4Philadelphia, PA, USA

BACKGROUND CONTEXT: Total disc replacement (TDR) is a recent

alternative treatment for symptomatic lumbar degenerative disc disease.

The results from the 2-level ProDisc�-L TDR (Synthes Spine Company,

L.P., West Chester, PA) show significant differences from the 2-level cir-

cumferential fusion results in the investigational device exemption (IDE)

study. The question arises as to whether multiple level surgery is as suc-

cessful as single level surgery in these two treatment options.