54S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S

STUDY DESIGN/SETTING: We reviewed a consecutive series of 300

one, two, three or four level instrumented fusions by a single surgeon at

a single institution. One hundred and fifty consecutive cases were con-

ducted in routine fashion with standardized preoperative and postoperative

antibiotic administration. Attention to intraoperative care and detail was

standardized with intraoperative pulsed wound lavage of 3 liters of sterile

saline completed prior to grafting and closure. One hundred and fifty con-

secutive cases were conducted identically save for a three minute wound

lavage of 3.5% betadine solution prior to the 3 liter sterile saline

irrigation.

PATIENT SAMPLE: Three hundred consecutive patients undergoing 1-4

level instrumented posterolateral fusions treated without or with dilute be-

tadine wound lavage as infection prophylaxis.

OUTCOME MEASURES: Demographics, health history and diagnosis

were collected for both groups. Preoperative and postoperative visual ana-

log pain values, ODI values, clinical examinations and work status were

documented.

METHODS: Physical exam and surgery was conducted by one surgeon.

Diagnosis for surgical care included spondylolithesis, degenerative scolio-

sis or flatback and the remainder spondylosis with herniation or stenosis.

Group 1 utilized rhBMP-2 with local bone as the graft material in 64%

cases, while Group 2 utilized rhBMP-2 with local bone in 94% of cases.

In all other cases iliac crest was utilized. Pedicle screw instrumentation

was used in all cases. Routine followup included physical exam, outcomes

evaluations with radiographs and/or CT scans. Statistical analysis of data

was conducted.

RESULTS: Mean age was 57.5 yrs in group 1 vs 55.0 yrs in group 2,

p5.05. Mean followup was 30mos vs 18.2 mos respectively. Mean levels

fused were 1.6 vs 1.7 and was not different between groups. 60.7% were

female in both groups. Mean wt was 192 lbs for both groups. Diabetics

comprised 12.7% of group 1 and 15.3% of group 2. Mean patient comor-

bidities were 2.5 vs 2.1 and not different between groups. In Group 1 stan-

dard prophylaxis yielded a 4.66% infection rate (6 deep/1 superficial)

while Group 2 dilute betadine lavage yielded a 0.66% infection rate with

p5.03. The lone infection in group 2 occurred in an obese diabetic patient

with a grade 2 lytic spondylolithesis. Both groups revealed statistical im-

provement in pre vs postoperative pain scores. Postoperative ODI was 16.8

vs 14.4 and not statistically different between groups. No adverse events

were documented with the use of betadine.

CONCLUSIONS: In this consecutive series, dilute 3.5% betadine lavage

for three minutes yielded superior infection rates compared to standard

care with minimal cost and risk to the patient.

FDA DEVICE/DRUG STATUS: BMP-2 Posterolateral Use: Investiga-

tional/Not approved.

doi: 10.1016/j.spinee.2009.08.127

104. Complications with rhBMP-2 in Posterolateral Spine Fusion:

886 Consecutive Cases

Steven Glassman, MD1, Jennifer Howard, MPH1, John Dimar, II, MD1,

John Johnson, MD1, Alexander Sweet, BS2, Greg Wilson, BS2,

Leah Carreon, MD, MSC1; 1Leatherman Spine Center, Louisville, KY,

USA; 2University of Louisville School of Medicine, Louisville, KY, USA

BACKGROUND CONTEXT: Bone Morphogenetic Protein (BMP) is

widely used as an ICBG substitute for posterolateral spine fusion (PSF).

While this application has been extensively studied in IDE trials and clin-

ical series, the serious complications reported for anterior cervical usage

have raised new concerns regarding potentially unidentified risks for

PSF as well. As complications are often reported in isolation, without

a clear denominator, actual complications rates may be difficult to

determine.

PURPOSE: To characterize perioperative complications and complication

rates in a large consecutive series of posterolateral spine fusion procedures

with rhBMP-2.

STUDY DESIGN/SETTING: Retrospective review of a consecutive

series.

PATIENT SAMPLE: 886 patients (547 females, 339 males), mean age

58.5 (19 to 90) years.

OUTCOME MEASURES: Observed complications.

METHODS: We reviewed inpatient and outpatient medical records for

a consecutive series of 886 patients who underwent PSF using rhBMP-2

between 2003 and 2006. Patients undergoing interbody fusion were ex-

cluded. Complications observed within a 3 month perioperative interval

were categorized as to etiology and severity. Wound problems were delin-

eated as wound infection, hematoma/seroma or persistent drainage/super-

ficial dehiscence. Neurologic deficits and radiculopathies were analyzed to

determine the presence of a clear etiology (screw misplacement) and to

identify any potential relationship to rhBMP-2 usage.

RESULTS: One or more complication or adverse event was observed in 168

of 886 patients (19.0%) during the 3 month perioperative period. Major com-

plications were reported in 79 patients (8.9%) and minor complications in 88

patients (9.9%). Major medical complications were pulmonary (19), cardiac

(7), renal (3) or other (5). Major surgical complications included deep wound

infection in 19 patients (2.1%) and hematoma with negative cultures in 8 pa-

tients (0.9%). Neurologic complications were related to screw malposition in

4 patients and epidural hematoma in 2 patients. New or more severe postop-

erative radicular symptoms were noted in 9 patients (1.1%). Psoas hematoma

was identified by CT scan in 8 patients (0.9%), and in 1 case was accompa-

nied by severe pain and reactive changes on MRI scan as previously seen with

osteolysis related to interbody BMP reactions.

Table. Summary of Complications.

CONCLUSIONS: This study analyzes a consecutive series of 886 patients

treated by posterolateral spine fusion using rhBMP-2 and reports a modest

complication rate consistent with literature standards for posterolateral fu-

sion with ICBG. In particular, the high incidence of wound edema or

swelling noted in anterior cervical spine fusion was not observed. Simi-

larly, the incidence of postoperative radiculopathy was only 1% suggesting

that BMP related radiculopathy, as reported with TLIF, does not occur with

rhBMP-2 in posterolateral fusion. Importantly, this large consecutive series

study design facilitates a reasonable determination of expected complica-

tion rates by providing an adequate denominator. Overall, this study dem-

onstrates a relatively low complication rate for posterolateral fusion using

rhBMP-2, and gives no indication of specific BMP related complications

with this application.

FDA DEVICE/DRUG STATUS: rhBMP-2 for Posterolateral Fusion: In-

vestigational/Not approved.

doi: 10.1016/j.spinee.2009.08.128