p80. longer surgical times may increase your complication rate

1
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, MD 1 , Peter Newton, MD 2 , Baron Lonner, MD 3 , Randal Betz, MD 4 , Tracey Bastrom, MA 2 , Michelle Marks, PT 5 ; 1 Wilmington, DE, USA; 2 Rady Children’s Hospital and Health Center - San Diego, San Diego, CA, USA; 3 New York University, New York, NY, USA; 4 Shriner’s Hospital for Children, Philadelphia, PA, USA; 5 ucson, 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, MD 1 , Antoine Tohmeh, MD 2 , Jonathan Hyde, MD 3 , Dan Cohen, MD 3 , Vedat Deviren, MD 4 , Kaveh Khajavi, MD 5 , Mark Peterson, MD 6 , Dzung Dinh, MD 7 , Leonel Hunt, MD 8 , Kade Huntsman, MD 9 , Robert Isaacs, MD 10 , William Richardson, MD 11 , James Malcolm, MD 12 , Ildemaro Volcan, MD 13 , S. Tim Yoon, MD 14 , William Smith, MD 15 , John Anson, MD 15 , Frank Phillips, MD 16 ; 1 Jefferson City, MO, USA; 2 Spokane, WA, USA; 3 Miami Beach, FL, USA; 4 University of California, San Francisco, San Francisco, CA, USA; 5 Decatur, GA, USA; 6 Medford, OR, USA; 7 Peoria, IL, USA; 8 Los Angeles, CA, USA; 9 Salt Lake City, UT, USA; 10 Durham, NC, USA; 11 Duke University, Durham, NC, USA; 12 Marietta, GA, USA; 13 Augusta, GA, USA; 14 Emory University, Atlanta, GA, USA; 15 Las Vegas, NV, USA; 16 Chicago, 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

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Page 1: P80. Longer Surgical Times May Increase Your Complication Rate

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