A Clinical Comparative Study on Low vs. Medium Viscosity PMMA Bone Cement in Percutaneous Vertebroplasty: Viscosity Associated with Cement Leakage

A Clinical Comparative Study on Low vs. Medium Viscosity PMMA Bone Cement in Percutaneous Vertebroplasty: Viscosity Associated with Cement Leakage

118S Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S CONCLUSIONS: Reduction of physiological curvatures in lumbar ...

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118S

Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S

CONCLUSIONS: Reduction of physiological curvatures in lumbar spine led to the increased risk of vertebral fracture by more than 3 fold. Importance of evaluating sagittal spinal alignment should be emphasized because it might indicate the risk of the first vertebral fracture, which is a strong predictor of subsequent fractures. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.307

P32. Prospective Comparative Analysis of Minimally Invasive Lumbar Posterolateral Fusion with Percutaneous Pedicle Screws vs. Conventional Approach for Degenerative Spondylolisthesis Yoshihisa Kotani, MD, Manabu Ito, MD, PhD, Kuniyoshi Abumi, MD, Hideki Sudo, MD, Shigeki Oshima, MD, Yuichiro Abe, MD, Akio Minami, MD; Dept. of Orthopedic Surgery, Hokkaido University, Sapporo, Japan BACKGROUND CONTEXT: To minimize the perioperative invasiveness and improve the quality of life, we have performed the minimally invasive lumbar posterolateral fusion (MIS-PLF) with percutaneous pedicle screw fixation for degenerative spondylolisthesis. PURPOSE: This study prospectively compared the clinical result of MISPLF with that of conventional PLF (Open-PLF) with emphasis on perioperative invasiveness and patients’ quality of life. STUDY DESIGN/SETTING: Clinical prospective cohort study. PATIENT SAMPLE: The total of eighty patients received single-level PLF for lumbar degenerative spondylolisthesis. There were forty-three cases of MIS-PLF and thirty-seven cases of Open-PLF. OUTCOME MEASURES: Analyzed parameters up to two years period included the operation time, intra and postoperative blood loss, OswestryDisability Index(ODI), Roland-Morris Questionnaire (RMQ), JOA score, and VAS scores of low back pain. The fusion rate and complications were also reviewed. METHODS: The surgical technique of MIS-PLF includes 4 cm of main incision and percutaneous pedicle screwing and rod insertion. The posterolateral gutter including the medial transverse process was decorticated and iliac bone graft was performed. RESULTS: The minimum follow-up period was twelve months postoperatively (Ave. 32 months). The average length of main incision was 4.5 cm in MIS-PLF and 12 cm in open-PLF, respectively. The average operation time was statistically equivalent between two groups. The intraoperative blood loss was significantly smaller in MIS-PLF group (181 cc) when compared to open-PLF group (453 cc). The postoperative bleeding on day 1 was also smaller in MIS-PLF group (210 cc) when compared to open-PLF group (406 cc).The ODI and RMQ score rapidly decreased at initial two weeks postoperatively in MIS-PLF group, and consistently maintained lower values than those in open-PLF group at 3, 6, 12 and 24 months postoperatively. The VAS score demonstrated further rapid decreases on postoperative day 1, 3, and 7 in MIS-PLF group. The fusion rate was statistically equivalent between two groups (98% vs. 100%), and no major complications were demonstrated. CONCLUSIONS: The minimally invasive lumbar posterolateral fusion with percutaneous pedicle screw system successfully decreased the perioperative invasiveness when compared to conventional open-PLF. The reduction of postoperative pain led to early extension of ADL, demonstrating the rapid improvement of several QOL parameters. This superiority in MIS-PLF group was maintained until two-year period, suggesting better long-term effect of less invasive PLF on low back pain and QOL. The MIS-PLF utilizing percutaneous pedicle screw fixation serves as a good alternative approach, obviating the needless interbody fusion in minimally invasive approach. Even in the minimum access surgery, the use of interbody fusion can be avoided with this surgical technique. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.308

P33. Percutaneous Vertebroplasty in Very Severe Osteoporotic Vertebral Compression Fractures: Feasible and Beneficial Marc J. Nieuwenhuijse, MD, Sander P.D. Dijkstra, MD, PhD, Arian R. van Erkel, MD, PhD; Leiden University Medical Center, Leiden, Netherlands BACKGROUND CONTEXT: Patient selection criteria in Percutaneous VertebroPlasty (PVP) should be individually optimized. PVP in patients presenting with collapse of the vertebral body to less than one-third of its original height, termed vsOVCFs, is considered technically demanding and by some a relative contra-indication. Reports explicitly assessing treatment of vsOVCFs are scarce and efficacy and safety of PVP in vsOVCFs is not firmly established. PURPOSE: Establishment of clinical outcome and technical feasibility of PVP in very severe Osteoporotic Vertebral Compression Fractures (vsOVCFs). STUDY DESIGN/SETTING: Prospective (cohort) follow-up study. PATIENT SAMPLE: Thirty-seven vsOVCFs in 34 patients were identified. OUTCOME MEASURES: PI-NRS, SF-36, cement leakage on postoperative CT-scanning, complications. METHODS: Follow-up was conducted using a 0–10 Pain Intensity Numerical Rating Scale (PI-NRS) and the Short Form 36 (SF-36) quality of life questionnaire before PVP and at 7 days (PI-NRS only), 1, 3 and 12 months after PVP. Injected cement volume and cement leakage was analyzed on direct post-operative CT-scanning. At six and 52 weeks and at suspicion, patients were analyzed for new fractures. RESULTS: Thirty-seven vsOVCFs in 34 patients were identified. Decrease in PI-NRS for average and worst back pain was respectively 2.5 and 2.9 points after 7 days and 2.4 and 2.7 points after 12 months. Increase in the SF-36 Physical Component Score was significant and clinically relevant with 2.0 at one moth and 2.6 at one year, whereas the Mental Component Score showed a gradual but eventually significant and clinically relevant increase of 7.5 points. Mean injected cement volume was 3.6 mL. Cement leakage was detected in 91.9% of treated vsOVCFs. No major and one minor complication, being temporal spontaneous focal resorption of the upper adjacent disc and vertebral body after intradiscal cement leakage, occurred. CONCLUSIONS: Patients with painful very severe OVCFs benefit from PVP. Although technically more demanding and with a higher procedural risk, ie, more frequent necessity of placement of a second needle, higher leakage incidence and greater leakage volumes, PVP is technically feasible and should not be withheld from these patients. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.309 P34. A Clinical Comparative Study on Low vs. Medium Viscosity PMMA Bone Cement in Percutaneous Vertebroplasty: Viscosity Associated with Cement Leakage Marc J. Nieuwenhuijse, MD, Sander P.J. Muijs, MD, Arian R. van Erkel, MD, PhD, Sander P.D. Dijkstra, MD, PhD; Leiden University Medical Center, Leiden, Netherlands BACKGROUND CONTEXT: Viscosity is the main characterizing parameter of PolyMethylMetAcrylate (PMMA) bone cement, currently the standard augmentation material in Percutaneous VertebroPlasty (PVP), and influences cement interdigitation and distribution inside the vertebral body as well as injected volume and extravasation, thereby affecting the clinical outcome of PVP. Currently, low, medium and high viscosity PMMA bone cements are used interchangeably. However, effect of viscosity on clinical outcome in patients with Osteoporotic Vertebral Compression Fractures (OVCFs) has not yet been explicit subject of investigation. PURPOSE: Comparison of outcome between patients treated PVP using low and medium viscosity PMMA bone cement. STUDY DESIGN/SETTING: Comparative, prospective follow-up study. PATIENT SAMPLE: Thirty consecutive patients who received PVP using low viscosity PMMA bone cement (OsteoPal-VÒ) for 62 OVCFs, followed by 34 patients who received PVP using medium viscosity PMMA bone cement (Disc-O-TechÒ) for 67 OVCFs.

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 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S OUTCOME MEASURES: PI-NRS, SF-36, Cement leakage on CTscanning, complications METHODS: Follow-up was conducted using a 0–10 Pain Intensity Numerical Rating Scale (PI-NRS) and the Short Form 36 (SF-36) Quality of Life questionnaire before PVP and at 7 days (PI-NRS only), 1, 3 and 12 months after PVP. Injected cement volume, degree of interdigitation and cement leakage was analyzed on direct post-operative CT-scanning. At six and 52 weeks and at suspicion, patients were analyzed for new fractures. RESULTS: Baseline characteristics were comparable between groups. Viscosity qualification was stated by the manufacturer. Results regarding PI-NRS and SF-36 were comparable between both groups. Postoperative comparison of injected cement volume, degree of interdigitation, proportion of bipedicular procedures, incidence of new vertebral fractures and complications revealed no differences between both groups. In the low viscosity group a significantly greater proportion of vertebrae showed cement extravastion (87.9% versus 71.6%, p50.029). A subsequent multiple logistic analyses identified cement viscosity as an independent risk factor for the occurrence of cement leakage (yes/no, OR: 2.925, 95%CI: [1.072 7.984]), p50.036, table). CONCLUSIONS: No major differences in clinical outcome after PVP in OVCFs using low and medium viscosity PMMA bone cement were found. Viscosity of PMMA bone cement was identified as an independent predictor of cement extravastion. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.310

P35. Sciwora in Adults - Is C4 the Soft Target? Rajeshwar N. Srivastava, MD; King Georges Medical College, CSM Medical University, Lucknow, India BACKGROUND CONTEXT: First described by Rang & Wilberger, SCIWORA was initially defined as a syndrome of traumatic myelopathy without vertebral column disruption as visualized on plain spine films, flexion-extension films, myelography or CT. The mean incidence was reported to be around 40% with majority (two thirds) in young child less than 8 to 10 years of age, less commonly in adolescents and rare in adults PURPOSE: We initiated a study to evaluate the incidence, prevalence and outcome of SCIWORA in adults. STUDY DESIGN/SETTING: Case series. PATIENT SAMPLE: Patients of spinal cord injury admitted in SCI Unit, KG Medical College, Lucknow. OUTCOME MEASURES: ASIA A-D without radiological evidence. METHODS: A study was undertaken to evaluate the incidence, prevalence and outcome of SCIWORA in adults. Beginning Jan 2004 and ending Dec 2005, 5180 patients were admitted in the Dept. of orthopedic Surgery at our institution. 708 of these (13.66%) were spinal cord injuries. 7 cases of adult SCIWORA were diagnosed in these two years. A case by case analysis was done and evaluated systematically. Following trauma, these patients had quadriparesis. Conventional radiographs were within normal limits. MRI showed lesions only in four and three had absence of any abnormal cord signal. RESULTS: The incidence of SCIWORA in adults was!1% of SCI (7/708), The mean age was 33.28 years, and male/female ratio was 6:1. The mode of injury was FFH in 4/7 (AK, MK, RV & S), RTA in 2/7 (KS & RB) and SOG in 1/7 (SK). Associated injuries were found in 3/7 (AK, KS & MK). Clinical presentation at admission was ASIA A in 2/7 (AK & RV), ASIA C in 2/7 (KS & RB) and ASIA D in 3/7 (MK, SK & S). ASIA A remained A and C&D recovered to ASIA E within 6 weeks. Neurological level was C4 in 6/7 (AK, KS, MK, RB, RV & SK), and? T2 in 1/7 (S). Motor level was C4 in 6/7 and T1 in 1/7. Sensory level was C4 in 4/7. (AK, KS, RB & RV), and normal sensations in 3/7 (MK, SK & S). At MRI, isolated cord contusion was found in 3/7 (RB, RV & S), combined contusion with hemorrhage in 1/7 (AK) and absence of abnormal cord signal in 3/7 (KS, MK & SK).

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CONCLUSIONS: SCIWORA is no more an injury of children. In our series a rare presentation is neurological level of C4 in all but one case. MRI findings for the cord are highly correlated with the prognosis - hemorrhage with poor outcome, contusion with moderate to good recovery and absence of abnormal cord signal with complete recovery. Management is essentially conservative and prognosis is better than that seen in patients with fracture or dislocation of cervical spine FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.311 P36. The Effects of Hospital and Surgeon Volume on Postoperative Complications Following Lumbar Spine Surgery Payam Farjoodi, MD, Richard L. Skolasky, PhD, Lee H. Riley, III, MD; Johns Hopkins Hospital, Baltimore, MD, USA BACKGROUND CONTEXT: Numerous studies have shown improved outcomes in patients treated by high-volume surgeons and hospitals. To our knowledge, no studies evaluate this relationship for lumbar spine surgery. PURPOSE: To determine the correlation between complication/mortality rate and surgeon/hospital volume. STUDY DESIGN/SETTING: Database study. PATIENT SAMPLE: The Nationwide Inpatient Survey (NIS) from 1992 through 2005. OUTCOME MEASURES: Primary outcomes were morbidity and mortality. METHODS: We identified 232,668 hospitalization records listed as posterolateral lumbar decompression with fusion and/or exploration/decompression of the spinal canal (based on ICD-9-CM codes). Identifier codes were used to stratify annual surgeon and hospital volume into quartiles. Patient demographics (age, race/ethnicity, socioeconomic status, primary insurance coverage, and comorbidity status) were recorded for each group. Mortality and morbidity were primary endpoints. Multivariate analysis assessed the association complication and mortality rates with surgeon and hospital volume. Logistic regression data were tabulated as odd ratios (OR) and 95% confidence intervals (CI) (statistical significance, p!.05). RESULTS: When controlled for other variables, mortality was significantly lower in the highest volume hospitals (OR 0.78, CI 0.66 to 0.89) and among the highest volume surgeons (OR 0.66, CI 0.59 to 0.89) than in their lowest volume counterparts. The complication rate was slightly lower in the highest volume hospitals (OR 0.94, CI 0.81 to 0.99) and significantly lower among the highest volume surgeons (OR 0.73, CI 0.68 to 0.91) than in their lowest volume counterparts. CONCLUSIONS: The complication rate associated with lumbar spine surgery is lower when patients are treated by high-volume surgeons and hospitals. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.312 P37. Presentation removed due to missing disclosure(s). doi: 10.1016/j.spinee.2010.07.313 P38. Inconsistency on the Surgical Decision Making for Scoliosis and Its Influencing Factors Xu Sun, MD, Yong Qiu, MD; The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China BACKGROUND CONTEXT: Scoliosis is a commonly seen spinal deformity, severe cases of which require surgical treatment. Surgery planning for scoliosis patients is an important but intricate process. The surgery decision is often made, based on many factors, including radiological, physical and cosmetic appearance, technical feasibility, economical support,

All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.