Measures of an Intracanal, Endoscopic Transforaminal Decompression Technique

Measures of an Intracanal, Endoscopic Transforaminal Decompression Technique

132S Proceedings of the NASS 28th Annual Meeting / The Spine Journal 13 (2013) 1S–168S 4 3 1 MD, FACS , Kern Singh, MD ; Chicago, IL, US; 2Midwest ...

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132S

Proceedings of the NASS 28th Annual Meeting / The Spine Journal 13 (2013) 1S–168S 4

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MD, FACS , Kern Singh, MD ; Chicago, IL, US; 2Midwest Orthopaedics at Rush University Medical Center, Chicago, IL, US; 3Rush University Medical Center, Chicago, IL, US; 4Northwestern Department of Orthopaedics, Chicago, IL, US BACKGROUND CONTEXT: Postoperative hematomas and neurologic complications are potentially catastrophic events that can occur after spine procedures. PURPOSE: A population-based database was analyzed to identify incidence, mortality, and risk factors associated with these complications after lumbar fusion (LF) and lumbar decompression (LD) without fusion. STUDY DESIGN/SETTING: Retrospective national database analysis. PATIENT SAMPLE: All patients that underwent LD or LF recorded in the Nationwide Inpatient Sample (NIS) database from 2002 to 2009. OUTCOME MEASURES: Incidences of postoperative hematomas and neurologic complications, length of stay, in-hospital costs, mortality, and risk factors. METHODS: Data from the NIS of the Health care Cost and Utilization Project was obtained from 2002-2009. Patients undergoing LD or LF for the diagnosis of lumbar degenerative disc disorder, herniated nucleus pulposus, radiculopathy, and spinal stenosis were identified. Incidences of hematomas, neurologic complications, and mortalities were calculated. Comorbidities were calculated using a modified Charlson Co-morbidity Index (CCI). SPSS v.20 was used for statistical analysis using Student T-test for discrete variables and c2 test for categorical data. Logistic regression was used to identify independent predictors of hematoma and neurologic complications. Due to the large sample of patients, a p-value of !0.0005 was used to denote statistical significance. RESULTS: A total of 578,457 lumbar procedures were identified in the database from 2002-2009. Incidences of hematomas were 6.3 and 14.1 per 1,000 cases for LD and LF groups, respectively (p!0.0005). Incidences of neurologic complications were 7.6 and 7.3 for LD and LF groups (p50.152). In both surgical groups, patients who suffered from hematomas and neurologic complications were older with greater co-morbidities (p! 0.0005). Compared to the LD group, LF patients that had complications incurred increased hospitalizations and costs. Independent predictors of hematomas were emergent admissions, Native-American ethnicity, pre-existing coagulopathy, paralysis, and fluid/electrolyte disorders. Independent predictors for neurologic complications were emergent/urgent admission, female gender, preoperative paralysis, obesity, and teaching hospital status. CONCLUSIONS: Our results identified risk factors of postoperative hematomas and neurologic complications after LD and LF procedures. Older patients with more co-morbidities are at increased risks for these complications. Our findings suggest patients undergoing fusions have greater hematoma risk, whereas patients undergoing decompressions are more prone to neurologic complications. Patients undergoing LD or LF procedures with preoperative paralysis or obesity warrant careful assessment and postoperative monitoring. Future studies should verify the efficacy of these protocols to improve patient care, decrease hospitalization, and reduce costs. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2013.07.340

P67. Epidemiological Trends in Interspinous Process, Pedicle-Based Dynamic Stabilization and Facet Replacement Devices Between 2007-2009 Sreeharsha V. Nandyala, BA1, Steven J. Fineberg, MD2, Alejandro Marquez-Lara, MD3, Matthew W. Oglesby, BA2, Miguel A. Pelton, BS2, Alpesh A. Patel, MD, FACS4, Kern Singh, MD3; 1Chicago, IL, US; 2Midwest Orthopaedics at Rush University Medical Center, Chicago, IL, US; 3Rush University Medical Center, Chicago, IL, US; 4 Northwestern Department of Orthopaedics, Chicago, IL, US BACKGROUND CONTEXT: Interspinous process spacers (ISP), pedicle based dynamic stabilization devices (PBDS), and facet replacement (FR)

devices were introduced as minimally invasive and motion-preserving alternatives for the treatment of lumbar degenerative pathology. PURPOSE: The purpose of this study was to analyze a population-based database to describe national trends of these procedures in terms of incidence, demographics, co-morbidities, cost and mortality. STUDY DESIGN/SETTING: Retrospective national database analysis. PATIENT SAMPLE: Patients that underwent ISP, PBDS, or FR that were recorded in the Nationwide Inpatient Sample (NIS) database from 20072009. OUTCOME MEASURES: Trends in incidence of procedures, patient demographics (age, gender, co-morbidities), length of stay, hospital costs, and mortality. METHODS: Data from the NIS of the Health care Cost and Utilization Project was obtained from 2007-2009. Patients undergoing insertion of ISPs, PBDS devices or FR devices for the diagnosis of lumbar radiculopathy, herniated nucleus pulposus, degenerative disc disorder, and spinal stenosis were identified. Co-morbidities were calculated using a modified Charlson Co-morbidity Index (CCI). Demographics (gender, age, and race), costs (adjusted for inflation), and mortality associated with these procedures were assessed. Statistical analysis was performed using Student T-test for discrete variables, and c2-test for categorical data. RESULTS: The number of patients undergoing motion-preserving procedures increased from 1,811 in 2007 to 6,394 in 2009. Co-morbidity scores, gender, teaching hospital status, and mortality did not change from 20072009. The average age, length of hospitalization, and costs for each patient increased over the 3-year period. Co-morbidity scores and age were highest in the ISP group versus both the PBDS and FR groups across all 3 years (P!0.0005). In-hospital costs increased for the ISP group while decreasing for the PBDS and FR groups. Hospitalization increased in the ISP and PBDS groups while decreasing in the FR group across all three years (p!0.0005). Mortality did not significantly change with use of these devices (p50.808). CONCLUSIONS: Our study demonstrates that use of motion-sparing devices have increased from 2007-2009. The primary increase in volume was due to the increasing number of ISP devices. Despite older patients with more co-morbidities undergoing ISP insertion, mortality was not higher than PBDS or FR patients. Patients undergoing PBDS insertion incurred the greatest hospitalization days and costs. We hypothesize that these increased costs and hospitalization days are due to the greater invasiveness and cost of implant of PBDS devices. All three devices appear to be safe treatments in the acute perioperative period with no differences in mortality. Durability of these treatments has yet to be clearly defined at the population level. FDA DEVICE/DRUG STATUS: Facet replacement devices (Investigational/Not approved). http://dx.doi.org/10.1016/j.spinee.2013.07.341

P68. Measures of an Intracanal, Endoscopic Transforaminal Decompression Technique Joseph A. Sclafani, MD1, Kamshad Raiszadeh, MD2, Choll W. Kim, MD, PhD2; 1University of California San Diego, San Diego, CA, US; 2Spine Institute of San Diego, San Diego, CA, US BACKGROUND CONTEXT: Intradiscal endoscopic procedures achieve decompression through indirect techniques. Recently developed intracanal endoscopic procedures (IC) utilize a more lateral transforaminal approach to allow decompression under direct visualization of the spinal canal. PURPOSE: This study is an assessment of IC outcome data obtained through post-hoc analysis of the MIS Prospective Registry. STUDY DESIGN/SETTING: Post-hoc analysis of multi-site, prospectively collected data. PATIENT SAMPLE: All patients were sampled from the MIS Prospective Registry database. OUTCOME MEASURES: Pre and postoperative data were collected using validated HRQOL tools.

Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.

Proceedings of the NASS 28th Annual Meeting / The Spine Journal 13 (2013) 1S–168S METHODS: Post-hoc analysis was performed on the MIS Prospective Registry database containing 485 patients. A subgroup of patients treated with the endoscopic IC technique was identified. Statistical analysis was performed using paired t-tests (p!0.05). RESULTS: A total of 86 IC patients with a median age of 49 years (range 18-89 years) were analyzed. Median hospital stay was 0 days. There were no intraoperative complications. Overall ODI scores were 43.4 preop (n583), 29.4 at 6 weeks postop (n545, p50.001) and 24.6 at 6 Months postop (n523, p50.001). There was significant overall VAS score improvement: preoperative VAS (back55.9, leg56.6, n578), 6 week postop (back53.3, leg53.4, n547, p50.05) and 6 month postop (back52.8, leg52.5, n524, p50.05). A subanalysis of IC patients with two distinct primary diagnoses was performed. Group IC-1 underwent treatment for disc herniation with radiculopathy (n529). The primary indication for group IC-2 was neuroforaminal stenosis (n510). Group IC-1 (disc herniation) showed improvement in ODI (18.4 points, p50.001, n529) and VAS (back51.7 points, leg 53.8 points, p50.001, n529) scores starting 6 weeks postop. Group IC-2 (foraminal stenosis) showed VAS score improvement (back53.7 points, leg 56.4 points, p50.05, n510) starting 6 weeks postop but no significant ODI improvement at any time point. One year re-operation rate was 1.8% for group IC-1 and 33% for group IC-2. CONCLUSIONS: The initial results of the MIS Registry IC subgroup (intracanal, transforaminal endoscopic lumbar surgery) show a significant clinical improvement when the technique is employed to treat patients with lumbar disc herniation. The treatment of foraminal stenosis can lead to improved short term clinical outcome but is associated with a high re-operation rate at 1 year postop. The long-term outcomes, together with higher level analysis of cost-effectiveness (cost/quality adjusted life year) will be forthcoming with the continued growth of the MIS Registry database. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2013.07.342

P69. Modified Growing Rod Technique for the Treatment of EarlyOnset Idiopathic Scoliosis Sinan Kahraman, MD1, Meric Enercan, MD1, Cagatay Ozturk, MD1, Gurkan Gumussuyu, MD1, Alaa Zakout, MD1, Azmi Hamzaoglu, MD2; 1 Istanbul Spine Center, Istanbul, Turkey; 2Istanbul, Turkey PURPOSE: This study introduces a new surgical strategy allowing spinal growth and lung development and controlling the apical rotation without fusion for the surgical treatment of early-onset idiopathic scoliosis. STUDY DESIGN/SETTING: Retrospective Level 4. PATIENT SAMPLE: Between the years of 2007 and 2011, 16 children (7 males, 9 females; with a mean age of 5.5 years, ranging from 2-8 years) with progressive scoliosis (average 68 degrees) were included in the study. METHODS: In the initial surgery; polyaxial pedicle screws were placed to the strategic vertebra (apical, end, intermediate and transitional zone vertebrae) after skin and subcutaneous tissue dissection without subperiosteal muscle dissection on midline. Then, rods were placed in situ after achieving correction with the help of manual traction (J-tongue from head and manual traction from lower extremities). The most proximal and most distal screws were fixed and the rest of the screws were left with nonlocked tap-screws. The lengthening re-operations were performed every 6 months. The patients were braced (TLSO) after surgeries. The coronal plane correction ratio, truncal height increase and complications were documented. RESULTS: Initial curve correction went from 68 (38-92) to an average of 20 (4-36) and maintained at 22 (4-36) at minimum two-year follow-up. Two of 16 patients underwent final permanent surgery after fifth lengthening surgery. In two of 16 patients, hybrid procedure was performed (apical vertebra resection þ growing rod). The average number of lengthening operations was 5.5. The average coronal plane correction was 65% and average truncal height increase was 13%. The truncal height increase significantly reduced after fifth lengthening surgery. In the sagittal plane; decrease of

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thoracic kyphosis was not seen (preoperative and last follow up mean thoracic kyphosis were 23.4 and 22.6 degrees). No patient had significant changes in the spinal cord monitoring. There was no infection. In one patient, instrumenation was elongated distally due to adding on deformity. The dislodgement of set screw in apical foundation was seen in 9 patients but, none needed any intervention before planned lengthening surgeries. CONCLUSIONS: Our new treatment strategy provides that the screws in apical and intermediate vertebra controlled the curve, prevents progression, maintains rotational stability and allows continuation of trunk growth. This strategy can also provide that there is no need to develop special instrument designs and products in this technique. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2013.07.343

P70. Changes in Objectively Measured Walking Performance, Function and Pain Following Surgery for Spondylolisthesis with Lumbar Spinal Stenosis Christy C. Tomkins-Lane, PhD; Mount Royal University, Calgary, AB, Canada BACKGROUND CONTEXT: Goals of spine surgery include relief of symptoms and increased function. In particular, performance (actual function in the usual environment) has recently been identified as an important outcome. While existing studies suggest that surgery improves pain and function, it remains to be seen whether such changes translate into increased performance in the community. PURPOSE: The purpose of this study was to examine changes in performance (day to day function) following surgery for spondylolisthesis and lumbar spinal stenosis. STUDY DESIGN/SETTING: Prospective study in University Spine Centre. PATIENT SAMPLE: All subjects were O50, and undergoing decompression with single level fusion for spondylolisthesis and associated lumbar spinal stenosis. OUTCOME MEASURES: 7-day accelerometry, Self-Paced Walking Test (SPWT), Oswestry Disability Index, Swiss Spinal Stenosis Questionnaire. METHODS: One week prior, and 6 months post-surgery subjects wore an activity monitor for 7 days, completed the Self-Paced Walking Test and a questionnaire. Walking performance was measured with activity counts and steps/day. Maximum continuous activity was defined as the maximum number of consecutive minutes above ’light intensity’ activity (O100 counts/min). RESULTS: Subjects (n517) had a mean age of 66.567.4 years and 50% were male. Significant improvements were seen at 6 months in self-reported function, walking capacity and pain, as measured by the ODI, Swiss Spinal Stenosis Questionnaire and pain scales (p!0.05). Measured walking capacity improved (767m to 1741m), as did total activity (789357 activity counts/week to 3343300), steps per day (3986 to 4376), and maximum continuous activity (5.6 minutes to 6.7), however none of these changes were statistically significant. CONCLUSIONS: Significant changes in self-reported function, walking capacity and pain were observed following surgery for spondylolisthesis with LSS. However, improvements in objectivity measured walking performance did not reach statistical significance. While a larger sample may show significant changes in performance, current results suggest that perceived improvements may not be fully reflected in changes in daily function. Given that improved function is a major goal of surgery, there is a need to further investigate the impact of interventions on performance, and to consider what the outcomes we choose are actually measuring. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2013.07.344

Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.