197. fusion topping with interspinous device: is it an option?

1
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, MD 1 , Christopher Bono, MD 2 , Natalie Warholic, MA 2 , William Reichmann, MA 2 , Kirkham Wood, MD 3 , Jeffrey Katz, MD 4 , Elena Losina, PhD 2 , Mitchel Harris, MD 2 ; 1 Harvard Combined Orthopaedic Program, Boston, MA, USA; 2 Brigham and Women’s Hospital, Boston, MA, USA; 3 Massachusetts General Hospital, Boston, MA, USA; 4 Harvard 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, MD 1 , Alan Hammer, MD 2 ; 1 Medway Maritime Hospital, Worcester Park, Surrey, United Kingdom; 2 Gillingham, 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, MD 1 , L.E.A. Kanim, MA 1 , Michael Kropf, MD 1 , Rick B Delamarter, MD 1 ; 1 Spine 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. 104S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S–205S

Upload: anand-agarwal

Post on 30-Nov-2016

215 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: 197. Fusion Topping with Interspinous Device: Is it an Option?

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.