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the complete deficit remains. Resulting diagnosis: Right femoral nerve injury caused by chemical neuritis during rhBMP-2 inflammatory phase. Patient 2: L2-5 XLIF with lateral plating and BMP. Six-month postoperative CT showed extensive ectopic bone formation through the psoas muscle at L4-5, the patient had severe right leg pain. The patient required revision surgery for removal of the lateral plate and lateral screws with exploration of the psoas for removal of ectopic bone (Figure 1). Patient 3: L2-5 XLIF with rhBMP-2. Postoperative motor evaluation showed full strength. By 2weeks postoperative, the patient developed left quadriceps weakness (2/5) with MRI showing psoas inflammation without hematoma or fluid collection. Quad weakness resolved by 3 months postoperative following aquatic and physical therapy. Patient 4. 52yo male treated for L4-5 grade I spondylolisthesis with XLIF, lateral plate, and interspinous plate. Follow-up CT showed significant ectopic bone within the iliopsoas muscle contralateral to the approach side. There were no symptoms associated with the bone growth and no revision was performed. Patient 5. 56yo male treated with an L4-5 XLIF. Immediate postoperative evaluation showed no motor or sensory deficits. On postoperative day 7, an anterior femoral cutaneous branch deficit was observed, which improved 6 months postoperatively. Patient 6. 44yo female treated with L4-5 XLIF following a failed nucleus replacement. No supplemental instrumentation was used. At 6 months postoperative, the patient developed severe (10/10) right left pain (contralateral to approach) and back pain. CT showed extensive ectopic bone growth into the neural foramen, which required a foraminotomy to address at 12 months postoperative. CONCLUSIONS: These cases of rhBMP-2 complications are consistent with recent literature, especially in similar reports of emerging radicular symptoms within several weeks of surgery in PLIF and TLIF performed with rhBMP-2. The mechanism for extra-discal damage, in this case, is assumed to be by migration of rhBMP-2, in an overly-active inflammatory phase, to the surrounding soft tissue – in these cases to the adjacent psoas, lumbar plexus, and neural foramen. FDA DEVICE/DRUG STATUS: BMP in cage other than LT cage for single-level ALIF (Not approved for this indication).
levels. Smokers-55, Nonsmokers-490; smokers were not discouraged from having surgery. Prior surgery: smokers-24, nonsmokers-210. Work status preop: working -195(sedentary-102, medium-61, heavy-9, student-4, unknown-19), retired-276, disabled-73. Excluded: non-fusion surgery, age ! 18 years. Clinical and radiographic data were collected preop, 1 year, 2 years, and latest follow-up. RESULTS: Follow-up averaged 5years (24-112months). There was no significant difference in complications between smokers and nonsmokers: nonunion-23(4%), adjacent fracture-16(3%), infection-13(2%), whether primary or revision surgery. Significant improvement was noted in VAS, Oswestry (ODI), and pain medication records among smokers and nonsmokers for all diagnostic groups, whether primary or revision surgery. SMOKERS: Primary surgery (VAS preop-7.1, 2 year- 4.1, p50.0026; ODI preop-51, 2 year-32, p50.0433), Revision surgery (VAS preop-7.3, 2 year-3.7 p50.0034; ODIpreop-56, 2 year-32, 50.0001). NONSMOKERS: Primary surgery (VAS preop- 5.8, 2 year-2.8,p!0.001; ODI preop-44.9, 2 year-24.8, p!0.001), Revision surgery. (VAS preop-6.6, 2 year-4.0 p!0.001; ODI preop-55, 2 year-36, p!0.001). WORK: Returned and remained working long-term: Smokers- 20/24(83%), Nonsmokers123/167(74%)(p50.450, Fischer’s exact test), no difference in time to return. Filed for disability after surgery: 4/24 smokers (17%), 5/167 nonsmokers (3%) (p50.016, Fischer’s exact test). CONCLUSIONS: Smokers and nonsmokers undergoing primary or revision spinal fusion for scoliosis, spondylolisthesis, and degenerative disease showed significant clinical improvement and a strong ability to return to work and remain working long-term in the largest series in the literature. Smokers had slightly more pain pre-op than nonsmokers, and were more likely to claim disability despite similar VAS and ODI improvement. BMP appears to negate the influence of smoking on clinical, functional, and occupational outcomes after instrumented spinal fusion, regardless of fusion length, diagnosis, or revision surgery. Other factors besides clinical and functional outcomes likely account for smokers being more likely to file for disability. FDA DEVICE/DRUG STATUS: BMP-2 use outside of an anteriorly placed LT cage (Not approved for this indication).
http://dx.doi.org/10.1016/j.spinee.2012.08.255 http://dx.doi.org/10.1016/j.spinee.2012.08.256 182. Smoking and Spinal Fusion with rhBMP-2: Long-Term Clinical, Functional and Occupational Outcomes Dennis G. Crandall, MD1, Matthew R. Wilson1, Jan Revella, RN1, Dustin Revella1, Ryan McLemore, PhD2; 1Sonoran Spine Center, Mesa, AZ, US; 2Banner Samaritan Hospital Orthopaedic Residency, Phoenix, AZ, US BACKGROUND CONTEXT: Smoking impairs bone healing and is associated with pseudoarthrosis and inferior clinical outcomes. In the era of BMP, the efficacy of spinal fusion in smokers has only been studied in one small series, with no available data on clinical outcomes. PURPOSE: This is the first report of long-term clinical, occupational, and functional outcomes comparing smokers to nonsmokers who were fused with posterior fusion and TLIF using BMP. STUDY DESIGN/SETTING: Retrospective review of prospectively collected outcomes PATIENT SAMPLE: Five hundred forty-five consecutive adults age 61 years (19-88) who underwent spinal fusion for degenerative, spondylolisthesis, or deformity at one center. OUTCOME MEASURES: Clinical: VAS pain scores, pain medication records; Functional: Oswestry Disability index (ODI); Occupational: work status pre-op and long-term, work type (sedentary, medium, heavy; retired, student, unknown), time to return to work. METHODS: All patients underwent spinal fusion for spondylolisthesis (180 patients, average 3 levels), degenerative disease (193 patents, average 3 levels), or deformity (172 patients, average 9 levels); All were fused with BMP-2, local autograft, and corticocancellous allograft: posterior fusion only- 98 patients, additional TLIFþBMP- 447 patients at average1.7
183. Decompression Alone is Effective in Lumbar Spinal Stenosis with Degenerative Spondylolisthesis Akira Miyauchi, MD; Hiroshima City Asa Hospital, Hiroshima, Japan BACKGROUND CONTEXT: Recently, decompression alone under microscopy or endoscopy for lumbar spinal stenosis (LSS) has developed into minimally invasive surgery, leading to satisfactory surgical results. Then, whether spinal fusion following decompression for LSS with degenerative spondylolisthesis (DS) is required or not is controversial. PURPOSE: The purpose of this clinical prospective study was to evaluate the effectiveness of decompression alone for LSS with DS. STUDY DESIGN/SETTING: A clinical prospective study. PATIENT SAMPLE: Ninety-six patients with LSS who had undergone decompression alone at the L4-5 level were evaluated with a more than 2 year follow-up period. This study excluded patients with previous lumbar surgery, concomitant disc herniation, spondylolysis, or vertebral compression fracture during the study period. METHODS: Decompression alone was performed under microscopy by removing the degenerative ligamentum flavum with the facet joints preserved. Being fixed against the anterior wall of the spinal canal due to adhesion, the nerve root was released to obtain its mobility and adequate decompression. the Patients were divided into 3 groups based on the forward slippage rate of L4 on L5 in the neutral position (% slip) as follows: group A (control), 51 patients with ! 10 % slip; group B, 30 patients with 10 to 20 % slip; and group C, 15 patients with $20 % slip. The clinical condition was estimated with the Japanese Orthopaedic Association scoring system (JOA score, ranging from 0 to 15 scale) and the recovery rate
All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.
Proceedings of the NASS 27th Annual Meeting / The Spine Journal 12 (2012) 81S–98S was calculated using Hirabayashi’s method. The clinical data were compared among the 3 groups. Statistical analysis was performed using a Spearman’s correlation coefficient, Kruscal-Wallis test, Scheffe posthoc test, Mann-Whitney’s U test, and Wilcoxon signed-ranks test with a risk of 5% being considered significant. RESULTS: Age at surgery, the preoperative JOA score, and the recovery rate averaged 68.0 years, 9.1 points, and 69.0%, respectively; there were 45 males and 51 females. The Follow-up period averaged 38.0 months and the recovery rate had no correlation with the age (rs 5 -0.11, p 5 0.25) and a negative correlation with the symptom duration (rs 5 -0.24, p 5 0.02). Among the 3 groups, the distribution of age at surgery, the symptom duration, preoperative JOA score and the follow-up period exhibited no difference from one another (p 5 0.53, 0.67, 0.72 and 0.81, respectively). The nerve root adhered to the anterior wall of the spinal canal more frequently in group C than in group B and C (p ! 0.05). The % slip increased significantly in groups B and C after surgery with an average increase rate of 3.5% and 2.0%, respectively, which had no significant difference (p 5 0.06). However, the JOA score of each group (A-C) was significantly improved (p ! 0.01) and the recovery rate was: mean (SD) 5 69.3 (26.2) %, 68.6 (23.8) %, and 69.1 (25.5) %, respectively without significant differences between these results (p 5 0.93). CONCLUSIONS: Decompression alone preserving the facet joints can provide LSS patients with DS with satisfactory surgical outcomes. The % slip increases significantly even after this minimally invasive surgery, which does not affect surgical outcomes. For this reason, the indication of spinal fusion for LSS with DS should be reconsidered and limited. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2012.08.257
Saturday, October 27, 2012 10:00 – 11:00 AM Concurrent Session: Surgical Complications 184. Use of Single-Dose Tranexamic Acid to Reduce Blood Loss in Operative Thoracolumbar Trauma: A Comparative Study Bhavuk Garg, MD1, Sarvdeep Dhatt, MD2, Soumya Chakraborty, MBBS, MS3; 1All India Institute of Medical Sciences, New Delhi, India; 2India; 3 PGIMER, Chandigarh, India BACKGROUND CONTEXT: Tranexamic acid is an inhibitor of fibrinolysis and thereby decreases blood loss in patients undergoing surgery. Its role in reducing blood loss in Hip and knee arthroplasty is proven. PURPOSE: This study was conducted to look its role in operative thoracolumbar trauma. STUDY DESIGN/SETTING: Prospective Randomized trial. PATIENT SAMPLE: Fifty-two patients. OUTCOME MEASURES: Intraoperative blood lossPostoperative blood lossNumber of blood transfusions required.Hemoglobin drop at 3rd dayIncidence of deep venous thrombosisD-dimer levels. METHODS: Fifty-two patients (May 2011-Nov 2011) with thoracolumbar trauma were block randomized to Tranexamic acid (15 mg/kg) given as a bolus intravenous injection or placebo (normal saline) given intravenously, 15 min before the incision. Allocation concealment was done with SNOSE method. All patients were operated by posterior approach and instrumentation. The intraoperative and postoperative blood loss and the number of blood transfusions required were recorded. The patients were screened for deep venous thrombosis with bilateral compression Ultrasonography on the 10th postoperative day. The hemoglobin level was measured preoperatively and on the 3rd postoperative day. The D-dimer levels were measured preoperatively and 24-h postoperatively.
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RESULTS: Patients receiving Tranexamic acid had a mean intraoperative blood loss of 410 ml (range, 300–510 ml) vs.615 ml (range, 515–750 ml) (P value ! 0.05) in patients receiving placebo, a postoperative blood loss of 210 ml (range, 150–325 ml) vs. 490 ml (range, 370–540 ml) (P value ! 0.05), and a total need for 8 blood transfusions versus 30 in placebo group. 6/26 patients in first group and 18/26 patients in the placebo group required transfusion. In placebo group, the mean fall in hemoglobin was 2.9 g/dl (range, 2.5–3.2) when compared to 1.6 g/dl (1.3–2) (P ! 0.05) in the Tranexamic group. At 24-h postoperatively, mean plasma D-dimer concentration in the Tranexamic group was half of that in the control group. No patient in either group had any evidence of deep vein thrombosis. CONCLUSIONS: Tranexamic acid given as a single preoperative bolus dose reduces intraoperative and postoperative and total blood loss and transfusion requirements in operative thoracolumbar trauma without any increased risk of thrombus formation. FDA DEVICE/DRUG STATUS: Tranexamic acid (Approved for this indication). http://dx.doi.org/10.1016/j.spinee.2012.08.259
185. The Relationship between the Number of Fusion Segments and Perioperative Complications in Elective Thoracolumbar Fusion Jacqueline Munch, MD, Natalie L. Zusman, Courtney D. Bell, Elizabeth G. Lieberman, Sawyer Smith, Alexander C. Ching, MD, Robert A. Hart, MD, Jung U. Yoo, MD; Oregon Health and Science University, Department of Orthopaedics and Rehabilitation, Portland, OR, US BACKGROUND CONTEXT: It is generally accepted that the rate of complications from spine surgery is directly related to the number of segments fused. Although multiple segment fusions have been linked to perioperative morbidity and mortality, there is no consensus regarding the definition of ‘‘multiple levels.’’ PURPOSE: To determine the risk of developing major medical and surgical complications and their relationship to the number of segments fused in elective thoracic/lumbar arthrodesis. STUDY DESIGN/SETTING: Retrospective cohort study at one institution. PATIENT SAMPLE: Seven hundred nine patients undergoing elective thoracic/lumbar fusion between 2007 and 2011. OUTCOME MEASURES: Presence of major medical and surgical complications occurring within the 30-day postoperative period. METHODS: The cohort was divided by the number of segments fused: 1, 2-3, 4-8, 9-22 segments; the means of each group followed an exponential progression (n2). The surgical and medical complication rates were analyzed. The rate of medical complications was further analyzed with respect to the pre-surgical American Society of Anesthesiologists (ASA) score by subdividing the patients into ASA 1-2 and ASA 3-4 groups. We determined the best fit function as a means of evaluating the mathematical relationship between the number of fusion segments and the complication rate. The correlation coefficients and p-values for the rates and segments were determined for each comparison. RESULTS: There was a different mathematical relationship between the number of fusion segments as compared to medical or surgical complication rates. The surgical complication rates were 3.9, 2.1, 7.0 and 16.3% for the four sequential groups, which was approximately a linear relationship (y 5 0.95x, r50.96, p!0.001). The medical complication rates for the four groups were 5.2, 14.8, 16.1, and 20.7%. This relationship was not linear. The rate sharply increased from the 1 segment group to the 2-3 segments group (increase of 7.3% per segment). In comparison, this increase was only 0.5% per segment between the 2-3 and the 9-22 fused segments groups. This relationship is logarithmic (y55.5Ln(x), r50.95, p!0.001). The rate of major medical complications behaved differently for patients with ASA 1-2 and ASA 3-4. For patients with ASA scores of 3-4, the complication rates were 5.8, 23.4, 21.5, and 29.4% as compared with 5.2, 7.8, 9.5,
All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.