p80. longer surgical times may increase your complication rate
TRANSCRIPT
available. In Group 1, 5/46 (10.8%) pts had a complication thought to be
related to rhBMP-2. Four of these patients had fluid collections behind the
cage causing radiculopathy and the other patient had osteolysis. The
rhBMP-2 complication rate in Group 2 was 3/26 (11.5%) pts, two of which
had osteolysis and one with fluid behind the interbody cage. In Group 3,
none of the 54 pts had a rhBMP-2 related complication. The interspace fu-
sion rate per level in Groups 1, 2, and 3 was 85.7%, 90.3%, and 95.3%,
respectively.
CONCLUSIONS: Complications resulting from the use of rhBMP-2 in
posterior interbody fusion can be decreased by decreasing the dose of
rhBMP-2. In this study, a total dose of 1.1 mg of rhBMP-2 in the interspace
combined with a morcellized allograft/demineralized bone matrix mixture
and contralateral posterolateral fusion resulted in a 95% interspace fusion
rate with no rhBMP-2 related complications.
FDA DEVICE/DRUG STATUS: Bone Morphogenetic Protein for Poste-
rior Interbody Fusion: Not approved for this indication.
doi: 10.1016/j.spinee.2009.08.338
P80. Longer Surgical Times May Increase Your Complication Rate
Suken Shah, MD1, Peter Newton, MD2, Baron Lonner, MD3, Randal Betz,
MD4, Tracey Bastrom, MA2, Michelle Marks, PT5; 1Wilmington, DE, USA;2Rady Children’s Hospital and Health Center - San Diego, San Diego, CA,
USA; 3New York University, New York, NY, USA; 4Shriner’s Hospital for
Children, Philadelphia, PA, USA; 5ucson, AZ, USA
BACKGROUND CONTEXT: Major spinal deformity surgery is stressful
on the patient due to prone positioning, blood loss, fluid shifts, anesthetic
effects and autonomic deregulation. Longer duration of surgery may lead
to adverse outcomes as the patient’s reserves are exhausted.
PURPOSE: The purpose of this study was to examine duration of surgery
as a variable on the incidence of complications.
STUDY DESIGN/SETTING: Patient data from a multicenter, prospec-
tively enrolled database were reviewed for surgical time and complications.
PATIENT SAMPLE: Patients who underwent surgery for AIS with greater
than 2 year follow up were included.
OUTCOME MEASURES: The incidence of complications was evaluated.
METHODS: Using a histogram analysis of surgical time, long duration of
surgery was defined as O 420 minutes and cases were grouped (I – greater
than 420 min and II – less than 420 min) and analyzed.
RESULTS: Patients in Group I (28/289) experienced 9 complications:
wound infections/dehiscence (4), implant-related (3), neurologic (1) and
excessive blood loss (1) for a rate of 32.1%. Patients in Group II (261/
289) had 24 complications for a rate of 9.2%. This difference in complica-
tion rate related to surgical time was significant (Chi Square p50.002).
There was no significant difference in the preoperative demographics of
the groups with regard to curve magnitude or co-morbidities.
Figure. Histogram illustrates distribution of surgical time for 289 cases. Scatterplot
shows a correlation of complications with increasing surgical time.
CONCLUSIONS: Surgical duration of greater than 420 minutes resulted
in an increased complication rate of 32.1%, a rate 3.5 times higher than
cases less than 420 minutes (9.2%). The most frequent complications were
wound issues, implant-related problems, neurologic events/alerts and ex-
cessive blood loss. Although complex procedures may have long operative
times and an increased complication rate in and of themselves, this data
may be useful in counseling the patient/family and perhaps in staging pro-
cedures when appropriate.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2009.08.339
P81. A Prospective, Multi-Center, Non-Randomized Evaluation of
XLIF in the Treatment of Adult Scoliosis: Mid-Term Radiographic
Outcomes
W.B. Rodgers, MD1, Antoine Tohmeh, MD2, Jonathan Hyde, MD3,
Dan Cohen, MD3, Vedat Deviren, MD4, Kaveh Khajavi, MD5,
Mark Peterson, MD6, Dzung Dinh, MD7, Leonel Hunt, MD8,
Kade Huntsman, MD9, Robert Isaacs, MD10, William Richardson, MD11,
James Malcolm, MD12, Ildemaro Volcan, MD13, S. Tim Yoon, MD14,
William Smith, MD15, John Anson, MD15, Frank Phillips, MD16; 1Jefferson
City, MO, USA; 2Spokane, WA, USA; 3Miami Beach, FL, USA; 4University
of California, San Francisco, San Francisco, CA, USA; 5Decatur, GA,
USA; 6Medford, OR, USA; 7Peoria, IL, USA; 8Los Angeles, CA, USA; 9Salt
Lake City, UT, USA; 10Durham, NC, USA; 11Duke University, Durham,
NC, USA; 12Marietta, GA, USA; 13Augusta, GA, USA; 14Emory University,
Atlanta, GA, USA; 15Las Vegas, NV, USA; 16Chicago, IL, USA
BACKGROUND CONTEXT: Surgical intervention in adult scoliosis pa-
tients has traditionally been by large open anterior and/or posterior proce-
dures, which can be accompanied by unacceptable morbidity and risk to
the patient. With XLIF, a wide interbody implant that spans the apophyseal
ring is placed minimally invasively. Implant placement realigns the end-
plates creating coronal and sagittal correction. Minimizing patient morbid-
ity, especially in high risk elderly patients with preexisting comorbidities,
is critical to rapid recovery of these patients. Minimally invasive treatment
of adult scoliosis can be achieved with the XLIF approach.
PURPOSE: To evaluate the radiographic outcomes of XLIF in the mini-
mally invasive treatment of adult scoliosis from a prospective, non-ran-
domized, multi-center IRB approved study.
STUDY DESIGN/SETTING: A prospective, non-randomized, multi-cen-
ter data collection study.
PATIENT SAMPLE: Eighty-four adult scoliosis patients treated at 14
centers across the country.
OUTCOME MEASURES: In this ongoing clinical trial, radiographic
outcomes including sagittal and coronal Cobb angles, balance, disc
height/subsidence, and fusion are collected preoperatively and at follow-
up visits out to 2 years. Additional clinical outcomes questionnaires
including VAS pain scores, Oswestry Disability Index (ODI), Treatment
Intensity Score (TIS), SF-36, and SRS-22 are also administered.
METHODS: Clinical, radiographic, and demographic data are collected
prospectively at the preoperative, surgical, postoperative, 6-week, 3-
month, 6-month, 12-month and 24-month visits for patients older than
45 years of age with XLIF procedures performed from T8 to L5, with
and without instrumentation, who have at least 10� of preoperative coronal
curvature. Perioperative data and improvement in clinical outcome scores
from baseline are evaluated to determine the clinically significant benefits
of the procedure.
RESULTS: Eighty-four patients (mean age: 68 years, range: 45-87 years)
underwent XLIF procedures at levels from T12 to S1 (mean: 2.99 levels/pt,
range: 1-6 levels). Operative time and EBL averaged 57.8 min and less
than 50 mL, respectively, per level treated. Posterior instrumentation was
used in 75.3%, 16.9% were standalone, and 7.8% used other fixation.
156S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S