100. Rates of Neurological Injury Associated with Spine Surgery Based on 108,419 Procedures: A Report of the Scoliosis Research Society Morbidity And Mortality Committee

100. Rates of Neurological Injury Associated with Spine Surgery Based on 108,419 Procedures: A Report of the Scoliosis Research Society Morbidity And Mortality Committee

52S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S FDA DEVICE/DRUG STATUS: This abstract does not discuss or inclu...

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52S

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

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.

doi: 10.1016/j.spinee.2009.08.122

doi: 10.1016/j.spinee.2009.08.123

99. Morbidity and Mortality in the Surgical Treatment of 605 Pediatric Patients with Isthmic or Dysplastic Spondylolisthesis: A Report from the Scoliosis Research Society Morbidity and Mortality Committee Kai-Ming Fu, MD, PhD1, Justin Smith, MD, PhD1, Christopher Shaffrey, MD1, Sigurd Berven, MD2, Paul Broadstone, MD3, Theodore Choma, MD4, Michael Goytan, MD, FRCSC5, Hilali Noordeen, MD6, Raymond Knapp7, Robert Hart, MD8, Reinhard Zeller, MD, FRCSC9, William Donaldson, MD10, David Polly, Jr., MD11, Joseph Perra, MD12, Oheneba BoachieAdjei, MD13; 1University of Virginia, Charlottesville, VA, USA; 2University of California, San Francisco, San Francisco, CA, USA; 3Erangler Medical Center, Chattanooga, TN, USA; 4University of Missouri-Columbia, Columbia, MO, USA; 5University of Manitoba, Winnipeg, Manitoba, Canada; 6The Royal National Orthopaedic Hospital and the Great Ormond Street Children’s Hospital, London, England, United Kingdom; 7Orlando, FL, USA; 8Oregon Health & Science University, Portland, OR, USA; 9 Hospital for Sick Children, Toronto, Ontario, Canada; 10University of Pittsburgh, Pittsburgh, PA, USA; 11University of Minnesota, Minneapolis, MN, USA; 12Twin Cities Spine Center, Minneapolis, MN, USA; 13Hospital for Special Surgery, New York, NY, USA

100. Rates of Neurological Injury Associated with Spine Surgery Based on 108,419 Procedures: A Report of the Scoliosis Research Society Morbidity And Mortality Committee D. Kojo Hamilton, MD1, Justin Smith, MD, PhD1, Christopher Shaffrey, MD1, Charles Sansur, MD1, Sigurd Berven, MD2, Paul Broadstone, MD3, Theodore Choma, MD4, Michael Goytan, MD, FRCSC5, Hilali Noordeen, MD6, Raymond Knapp7, Robert Hart, MD8, Reinhard Zeller, MD, FRCSC9, William Donaldson, MD10, David Polly, Jr., MD11, Joseph Perra, MD12, Oheneba Boachie-Adjei, MD13; 1University of Virginia, Charlottesville, VA, USA; 2University of California, San Francisco, San Francisco, CA, USA; 3 Erangler Medical Center, Chattanooga, TN, USA; 4University of MissouriColumbia, Columbia, MO, USA; 5University of Manitoba, Winnipeg, Manitoba, Canada; 6The Royal National Orthopaedic Hospital and the Great Ormond Street Children’s Hospital, London, England, United Kingdom; 7Orlando, FL, USA; 8Oregon Health & Science University, Portland, OR, USA; 9Hospital for Sick Children, Toronto, Ontario, Canada; 10 University of Pittsburgh, Pittsburgh, PA, USA; 11University of Minnesota, Minneapolis, MN, USA; 12Twin Cities Spine Center, Minneapolis, MN, USA; 13Hospital for Special Surgery, New York, NY, USA

BACKGROUND CONTEXT: Prior reports suggest high complication rates for the surgical treatment of pediatric isthmic and dysplastic spondylolisthesis, but due to their relatively low prevalence, useful estimates of complications remain limited. PURPOSE: The Scoliosis Research Society (SRS) prospectively collects morbidity and mortality (M&M) data from its members. We used these data to assess the rates of complications following surgery for isthmic or dysplastic spondylolisthesis in pediatric patients. STUDY DESIGN/SETTING: This study was a retrospective review of a prospectively collected, multicentered database. PATIENT SAMPLE: The patient population consisted of consecutively reported cases from the SRS M&M database from 2004 to 2007. OUTCOME MEASURES: The primary outcome measure was whether or not perioperative complications occurred. METHODS: Patients who underwent surgical treatment for isthmic or dysplastic spondylolisthesis from 2004-2007 were identified from the SRS M&M database. Inclusion criteria for analysis included: age #21 and a primary diagnosis of isthmic or dysplastic spondylolisthesis. Statistical comparisons for assessment of differences in rates of complications were based on two-sided Fisher’s exact test, with P!0.05 considered significant. RESULTS: Of 25,432 pediatric cases reported, there were a total of 605 (2.4%) cases of pediatric dysplastic (n562, 10%) and isthmic (n5543, 90%) spondylolisthesis, with a mean age of 15 years (range: 4-21). Approximately 50% presented with neural element compression, and less than 1% of cases were revisions. Surgical procedures included fusions in 92%, sacral dome osteotomies in 39% and reductions in 38%. The overall complication rate was 11%. The most common complications included postoperative neurological deficit (n531, 5.1%), dural tear (n58, 1.3%) and wound infection (n512, 2.0%). Perioperative deep venous thrombosis and pulmonary embolus were reported in 2 (0.3%) and 1 (0.2%) patients, respectively. Compared with procedures not including reduction, cases including reduction had a significantly greater incidence of neurological deficits (10.0% versus 2.1%, P#0.001) and a significantly higher overall rate of complications (14.4% versus 8.0%, P50.01). CONCLUSIONS: Pediatric isthmic and dysplastic spondylolisthesis are relatively uncommon disorders, representing only 2.4% of pediatric spine procedures in the present study. The large series of these cases collected by the SRS demonstrates a relatively high rate of complications associated with their surgical treatment, consistent with prior reports of smaller series, and provides surgeons with potentially useful information for comparison of outcomes and preoperative counseling.

BACKGROUND CONTEXT: Neurological injury is a potential complication of spine surgery. The rates at which these injuries occur differ based on the type of pathology and complexity of the procedure. Estimation of these rates is important for preoperative patient counseling and to serve as general benchmarks for efforts to improve patient care. Previously reported rates of neurological injury associated with spine surgery vary widely and are often limited by small sample size and data generated from a single operating surgeon. PURPOSE: The Scoliosis Research Society (SRS) prospectively collects morbidity and mortality (M&M) data from its members. We used these data to better estimate the rates of neurological injury associated with spine surgery. STUDY DESIGN/SETTING: This study was a retrospective review of a prospectively collected, multicentered database. PATIENT SAMPLE: The patient population consisted of consecutively reported cases from the SRS M&M database from 2004 to 2007. OUTCOME MEASURES: The primary outcome measures were whether patients had a neurological injury associated with surgery and the extent to which injuries recovered. METHODS: The SRS M&M database was queried to identify cases complicated by neurological injury from 2004 to 2007. Injuries were defined as nerve root injury (NRI), cauda equina injury (CEI), and spinal cord injury (SCI). Recovery was stratified into complete, partial or none. Rates of neurological injury were determined based on whether the surgery was primary or revision, whether implants were used, whether patients were adult ($21) or pediatric (!21), and based on type of spinal pathology, including spondylolisthesis, scoliosis, kyphosis, and cervical and lumbar degenerative disc disease. RESULTS: Of the 108,419 cases reported, neurological injury was documented in 1065 (1.0%), including 665 (0.6% overall, 63% of deficits) with NRI, 106 (0.1% overall, 10% of deficits) with CEI and 293 (0.3% overall, 27% of deficits) with SCI. Rates of NRI, CES, and SCI were calculated based on diagnosis, and a subset of these rates is shown in the table. Revision cases (n516,503) had a 44% higher overall rate of operative neurological injury (1.3%) compared with primary cases (n591,916; 0.9%). Pediatric cases (n525,432) had a 56% higher rate of overall neurological injury (1.4%) compared with adult cases (n582,082; 0.9%), likely reflecting the greater proportion of complex procedures performed in the pediatric population in this series. The rate of neurological injury for cases with implants (n574,114) was double the rate for cases without implants (n534,305), 1.2% versus 0.6%, respectively. Neuromonitoring was used for 67% of all cases overall. NRI, CEI, and SCI were detected intraoperatively by monitoring in 11%, 8%, and 40% of cases, respectively.

Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S CONCLUSIONS: Our data demonstrate that, even among skilled spinal deformity surgeons, neurological injury is an inherent potential complication of spine surgery. These data provide general benchmarks rates for neurological injury with spine surgery as a basis for patient counseling and for on-going efforts to improve safety of care. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.124

101. Sex Life and Sexual Function in Men and Women before and after Total Disc Replacement Compared to Posterior Lumbar Fusion Svante Berg, MD1, Hans Tropp, PhD2; 1Stockholm, Sweden; 2Ortopedic Clinic, University Hospital, Linko¨ping, Sweden BACKGROUND CONTEXT: Sex life and sexual function may be affected by low back pain. Sexual dysfunction after anterior lumbar fusion is reported in both men and women, but is mainly focused on impaired male biological function (retrograde ejaculation), as this may cause infertility. This has led to concerns over whether anterior surgery should be avoided in males, at least in younger age groups. PURPOSE: To investigate how chronic low back pain (CLBP) of assumed discogenic origin affected sex life and sexual function in patients considered for surgical treatment, and whether this was affected by the surgical treatment (TDR or PLF/PLIF), and if so, whether there were differences between the surgical procedures undertaken. STUDY DESIGN/SETTING: A randomised controlled trial (RCT) comparing total disc replacement (TDR) using three different prostheses, and instrumented spine fusion, either performed as a posterior lumbar fusion (PLF), or as a posterior lumbar interbody fusion (PLIF). PATIENT SAMPLE: 152 patients were included in this RCT in order to compare the effect on CLBP of either TDR through an anterior retroperitoneal approach, or instrumented posterior lumbar Fusion, PLF or PLIF. OUTCOME MEASURES: Follow-up was one and two years. Clinical outcome measured as back pain (VAS 0-100), function (ODI 0-100) and quality of life (EQ5D 0-1) was assessed using data from the Swedish Spine Register (‘‘SweSpine’’). In ODI, one question, ODI8, reflects the impact of back pain on sex life. This question was analysed separately. Patients also answered a gender specific questionnaire preoperatively and at two year follow-up in order to determine sexual dysfunction of erection, orgasm and ejaculation. METHODS: Patients were postoperatively compared to their preoperative data, and changes in sex life and sexual function were compared to clinical outcome data on pain, function and quality of life. Postoperative changes in sex life and sexual function were compared between the TDR group and the Fusion group. RESULTS: Before surgery, 34% reported that their sex life caused some extra low back pain, and an additional 31% that their sex life was severely restricted by low back pain. After surgery, sex life improved in both groups, with a strong correlation to a reduction of low back pain. The gender specific questionnaire used to measure sexual function revealed no negative effect of TDR or Fusion in men regarding erection or retrograde ejaculation. However, 26% of all men in the Fusion group, compared with 3% in the TDR group, reported postoperative deterioration in the ability to achieve orgasm, despite a reduction of low back pain. CONCLUSIONS: Impairment in sex life appears to be related to CLBP. An improvement in sex life was positively correlated to a reduction of low back pain. TDR in this study, performed through an anterior retroperitoneal approach, was not associated with more sexual dysfunction compared with instrumented PLF or PLIF. Sexual function expressed as orgasm, deteriorated in males in the fusion group postoperatively in spite of this group reporting less low back pain after two years. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.125

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102. Does Prophylactic Aspirin Increase Operative Blood Loss in Spinal Surgery? Seok Bong Kang, MD1, Kyu Jung Chom, MD2, Jae Hoon Jung, MD2, Se Jin Jung, MD2, Seung-Rim Park, MD2; 1Inha Univesity, Incheon, South Korea; 2Incheon, South Korea BACKGROUND CONTEXT: Low dose aspirin is administered chronically for the prevention of cardiovascular disease in the older population. It is recommended to discontinue aspirin for 7 days before elective spinal surgery. PURPOSE: This study was conducted to determine whether prophylactic aspirin does not increase the perioperative blood loss or complications related to bleeding if it is stopped for 7 days before the surgery. STUDY DESIGN/SETTING: Retrospective study. PATIENT SAMPLE: A total of 76 patients were divided into two groups (aspirin group vs control group) based on the aspirin ingestion history. The aspirin group included 38 patients who have taken 100 mg aspirin everyday for average 40.3 months. They stopped aspirin for at least 7 days before surgery (mean 13days). The control group included 38 patients who have not taken aspirin before surgery. This study enrolled the cases with same diagnosis and same procedures. The diagnosis was spinal stenosis. All the patients underwent same procedures, which were posterior decompression, posterior instrumentation and posterolateral fusion. No patients had history of coagulopathy, abnormal coagulation factors (PT, aPTT), and any medication related to hemostasis before surgery except nonsteroidal anti-inflammatory drugs. OUTCOME MEASURES: Clinical outcomes were assessed with Oswestry disability index. METHODS: Hospital records were reviewed for the blood loss and transfusion during surgery and after surgery, central venous pressure, operation time. Intra and perioperative complications related to blood loss were investigated. RESULTS: The mean age was 68.5 years in aspirin group and 69.1 years in control group. The mean number of levels fused was 2.1 segments in both groups. The additional posterior interbody fusion was performed in 19 patients of the aspirin group, and in 15 patients of the control group. During surgery, the estimated blood loss was 855.3 cc in the aspirin group and 840.8 cc in the control group with no statistical difference (p50.84). The RBC blood transfusion during surgery was not different in both groups 2 units in the aspirin group and 1.8 units in the control group. There was a statistical difference in the blood loss after surgery. The blood loss through Hemo-Vac drain after surgery was 864.4 cc in the aspirin group, whereas 458.4 cc in the control group (p!0.001). Therefore, the transfusion requirement after surgery was 2.4 unit in the aspirin group, and 1.5 unit in the control group (p50.03). There was no significant difference in the operation time, and central venous pressure during surgery between the two groups. And the incidence of complication(infection, deep vein thrombosis and pulmonary emobolism etc) was not different between both groups. CONCLUSIONS: The intraoperative blood loss during spinal fusion surgery was not increased in the patients with the prophylactic aspirin if it was stopped taking for 7 days. However, the blood loss drained after surgery was significantly more in the patients who had aspirin, despite cessation of taking aspirin. Therefore, we should check the bleeding tendency and monitor blood loss carefully in the patients with history of taking aspirin. FDA DEVICE/DRUG STATUS: Aspirin: Approved for this indication. doi: 10.1016/j.spinee.2009.08.126

103. Dilute Betadine Wound Lavage for Surgical Wound Prophylaxis James Hardacker, MD, Thomas Hardacker; The Spine Institute, Carmel, IN, USA BACKGROUND CONTEXT: Spine surgical wound care has received renewed interest as hospitals face new regulations and altered reimbursements for surgical complications. We undertook a new method of infection control utilizing dilute betadine wound lavage as an adjuvant to standard prophylaxis for spinal reconstructions. PURPOSE: To evaluate the safety and efficacy of dilute betadine wound lavage as a prophylatic measure to control surgical wound infection.