197. fusion topping with interspinous device: is it an option?
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104S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S–205S
alone animals. The data supports the rationale of acutely decompressing
the subarachnoid space following a compressive spinal cord injury.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2009.08.237
196. Type II Odontoid Fractures in the Elderly: Analysis of
Mortality and Outcome Based on Intervention
Andrew Schoenfeld, MD1, Christopher Bono, MD2, Natalie Warholic, MA2,
William Reichmann, MA2, Kirkham Wood, MD3, Jeffrey Katz, MD4,
Elena Losina, PhD2, Mitchel Harris, MD2; 1Harvard Combined
Orthopaedic Program, Boston, MA, USA; 2Brigham and Women’s
Hospital, Boston, MA, USA; 3Massachusetts General Hospital, Boston,
MA, USA; 4Harvard Medical School, Boston, MA, USA
BACKGROUND CONTEXT: Despite their relatively high incidence,
treatment of odontoid fractures in elderly patients remains controversial.
Some have proposed surgical treatment is superior for all patients, while
others have suggested nonoperative treatment for the majority of these in-
juries. Adding further controversy, elderly patients with odontoid fractures
have been reported to be at higher risk for complications, especially in the
event of halo application.
PURPOSE: To define the influence of age and treatment, adjusting for
a number of co-morbidities, on mortality in elderly patients with acute type
II odontoid fractures.
STUDY DESIGN/SETTING: Retrospective series at a Level I Univer-
sity-affiliated trauma center.
PATIENT SAMPLE: 156 patients (age 65 years or older) who sustained
type II odontoid fractures.
OUTCOME MEASURES: Mortality at 3 month and 1, 2 and 3 years
from injury.
METHODS: An institutional Research Patient Data Registry (RPDR) was
utilized to identify all type II odontoid fractures sustained by patients age
65 and older from 1991-2006. Demographic information, date of injury, in-
jury mechanism, fracture classification, associated injuries, treatment type,
co-morbidities, post-treatment complications, and outcome/mortality were
recorded. Data was analyzed by stratifying patients by age (65-74, 75-84,
85þ) and treatment type (operative or non-operative treatment, and halo or
collar immobilization). The chi-square test of independence was used to
compare mortality among groups. The Breslow-Day test was used to con-
trol for the effect of treatment by age on mortality.
RESULTS: 156 patients met the inclusion criteria. The average age of
the cohort was 81.5 years. One-hundred and twelve patients were treated
non-operatively while 44 patients underwent surgery. Of those managed
non-operatively, 28 (25%) were treated with halo vest immobilization.
The mortality rate for the entire cohort was 21% at 3 months, 31% at
1 year, 37% at 2 years, and 39% at 3 years. At 3-year follow-up 29%
of patients age 65-74 had died, while 35% of patients 75-84 and 49%
of patients over age 85 died. Eleven patients who had been treated surgi-
cally died within 3 years of their odontoid fracture, while 51 individuals
managed non-operatively died during the same time-period. The operative
group had a lower risk of mortality than the non-operative group, al-
though this difference only approached significance with the available
numbers(p 5 0.06). Kaplan-Meier analysis showed a protective effect
of surgery for patients 65-84 (18% operative mortality vs. 41% non-oper-
ative mortality). There was no survival advantage for patients 85 and over
treated surgically, with 50% mortality in both treatment groups. Patients
treated with halo-vest immobilization did not have a significantly in-
creased risk of mortality compared to those treated with surgery or cervi-
cal orthosis.
CONCLUSIONS: These data suggest that surgery may improve survival
of elderly patients less than 85 years with type II odontoid fractures. Only
25% of patients treated surgically were found to have died at 3-years post
injury compared with 46% of individuals managed non-operatively.
Findings could reflect confounding by indication and warrant further inves-
tigation. This series represents the largest single study of outcomes in el-
derly patients with acute type II odontoid fractures and mid-range follow-
up.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2009.08.238
197. Fusion Topping with Interspinous Device: Is it an Option?
Anand Agarwal, MD1, Alan Hammer, MD2; 1Medway Maritime Hospital,
Worcester Park, Surrey, United Kingdom; 2Gillingham, United Kingdom
BACKGROUND CONTEXT: Lumbar spine fusion has relatively good
results in appropriately selected patients but still questions remain concern-
ing the abnormal segment next to a segment fused or patients with multiple
level problems. The dilemma is how to treat an abnormal segment if fusion
is too aggressive intervention for that segment. If left alone will the out-
come of fusion surgery will be affected and would the patient require fur-
ther surgery later?
PURPOSE: The aim of this clinical audit (service evaluation) was to eval-
uate if an abnormal level next to the level fused is treated by topping with
interspinous device will the outcome be different compared to another
group treated with stand alone fusion. Will this save further revision for
the hospital and in turn save money and resources.
STUDY DESIGN/SETTING: N/A.
PATIENT SAMPLE: N/A.
OUTCOME MEASURES: N/A.
METHODS: 110 patients were treated either with interspinous spacer or
not depending upon the disease state. There were 62 females and 48 males
in this service evaluation (clinical Audit) . 58 of them had topping up with
interspinous spacer 52 had stand alone fusion. The patients were evaluated
in regular visits to the clinic at 3 month, 6 month, 12 month, and 24 month
with VAS score for back pain and leg pain, Oswestry disability index.
RESULTS: The results of the data showed that with a preoperative VAS
score of 9 in both groups, postoperative the VAS score was 4 for control
group and 2 for topping group and further follow up from 3 months to
24 months showed VAS score to increase in the fusion group of patients
but to decrease in topping group of patients. Similarly the Oswestry score
was found to be better in the topping group compared to stand alone.
CONCLUSIONS: In conclusion this clinical audit (service evaluation)
shows that patients treated with topping up next to the level of fusion
did better than stand alone fusion. This short term follow up of 24 months
shows good results.
FDA DEVICE/DRUG STATUS: Coflex Interspinous Device: Approved
for this indication; Diem Interspinous Device: Approved for this
indication.
doi: 10.1016/j.spinee.2009.08.239
198. Radiographic Range of Motion is Related to Clinical Outcomes
in Lumbar Artificial Disc Replacement Patients: One Site Analysis
of 219 Patients with Minimum 2 Year Follow-Up, USA-FDA IDE
Study
Hyun Bae, MD1, L.E.A. Kanim, MA1, Michael Kropf, MD1, Rick
B Delamarter, MD1; 1Spine Research Foundation, Spine Institute, Santa
Monica, CA, USA
BACKGROUND CONTEXT: Few studies have reported on the associa-
tions among range of segmental motion (ROM) and outcomes after lumbar
ADR. Maintenance of ROM has been reported at 5 to 10 degrees for Pro-
Disc-L patients. Data on how ROM relates to self-reported outcomes have
not yet been reported yet are also important considerations for efficacy in
evidence based medicine. Since ProDisc-L is intended to allow motion,
there is interest in relationships ROM and self-reported outcomes.