103. Dilute Betadine Wound Lavage for Surgical Wound Prophylaxis

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.

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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 conducted 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 consecutive 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 betadine wound lavage as infection prophylaxis. OUTCOME MEASURES: Demographics, health history and diagnosis were collected for both groups. Preoperative and postoperative visual analog 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 scoliosis 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 comorbidities were 2.5 vs 2.1 and not different between groups. In Group 1 standard 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 improvement 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: Investigational/Not approved.

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 excluded. Complications observed within a 3 month perioperative interval were categorized as to etiology and severity. Wound problems were delineated as wound infection, hematoma/seroma or persistent drainage/superficial 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 complications 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 patients (0.9%). Neurologic complications were related to screw malposition in 4 patients and epidural hematoma in 2 patients. New or more severe postoperative 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 accompanied by severe pain and reactive changes on MRI scan as previously seen with osteolysis related to interbody BMP reactions.

doi: 10.1016/j.spinee.2009.08.127

Table. Summary of Complications.

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 clinical 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.

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 fusion with ICBG. In particular, the high incidence of wound edema or swelling noted in anterior cervical spine fusion was not observed. Similarly, 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 complication rates by providing an adequate denominator. Overall, this study demonstrates 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: Investigational/Not approved. doi: 10.1016/j.spinee.2009.08.128