Proceedings of the NASS 30th Annual Meeting / The Spine Journal 15 (2015) 87S–267S P55. The Influence of Preoperative Disc and Prosthesis Heights Ratio on Postoperative Range of Motion and Sagittal Balance Two Years after Cervical Arthroplasty Patrick Fransen, Vincent Pointillart, MD, PhD1, Nils Hansen-Algenstaedt, MD2, Athanasios Chatzisotiriou, MD, PhD3, David C. Noriega, MD4; 1 Centre Hospitalier Universitaire Pellegrin, Bordeaux Cedex, France; 2 Orthocentrum Hamburg, Hamburg, Germany; 3Thessaloniki, Greece; 4 Valladolid, Spain BACKGROUND CONTEXT: Total disc replacement (TDR) is widely used as alternative treatment to fusion for symptomatic cervical disc degenerative diseases. Its advantages (ie, functional improvement, preservation of motion and possibly protection of the adjacent segment) are supported by literature data. The influence of the size of prosthesis on surgical outcomes has been less studied and we could not find any data on its correlation with preoperative disc height. PURPOSE: The aim of current analysis is to evaluate the relationship between surgery outcomes assessed two years postoperatively, and preoperative disc height (PDH)/implant height (BCH) ratio, in patients treated by TDR with a semi constrained prosthesis (BAGUERAÒC, Spineart Inc, Switzerland), using a multicentric prospective database. STUDY DESIGN/SETTING: An independent retrospective analysis of clinical and radiographic data was conducted for 99 patients treated with cervical arthroplasty with a two-year follow-up. PATIENT SAMPLE: We included 99 patients (46 males, 53 females), age mean 43.2 (29 to 70) years at surgery time, all treated at 1 to 3 levels. Overall, 123 prosthesis (5, 6, 7 mm height) were implanted: 70, 49, 4 %, respectively. OUTCOME MEASURES: Pre- and postoperatively radiographic data were extracted by an independent evaluator from dynamic lateral radiographs: disc height, ROM (segmental, overall and at the upper level), segmental and overall lordosis. Self-reported questionnaires (VAS, NDI, SF-36) were used for clinical assessment. METHODS: Implant size effect and relationship between PDH/BCH ratio and clinical and radiographic parameters, assessed 2 years after surgery, were respectively analysed. RESULTS: We observed highest mean segmental ROM (8.8 ) with a 5mm BCH, but better NDI, VAS and SF-36 scores with 6 mm BCH. The PDH/BCH ratio mean was 0.6 (0.5 to 1.5): 74.3% less than 0.9, 17.7% between 0.9-1.1, 8% greater than 1.1. It was significantly correlated (-0.34, p!0.01) with overall ROM, uncorrelated with segmental ROM, lordosis angles and clinical outcomes. Higher correlation (-0.59, p50.04) with overall ROM was observed for PDH/BCH ratio between 0.9-1.1. The PDH/BCH ! 0.9 was associated with lowest NDI and VAS Neck and PDH/BCH O 1.1 with lowest VAS Arm. CONCLUSIONS: Analysed data further demonstrate the clinical benefits of TDR. Despite the lack of correlation with clinical outcomes, better results were observed with small (þ10%) difference between implant size and preoperative disc height. The surgeon may have to choose the implant in order to open the disc height even if this may reduce mobility. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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PURPOSE: In this study, we examine CDA patient data from an FDA IDE clinical trial in order to determine if anterior and posterior coverage of the vertebral endplate is associated with HO. Additionally, we aim to determine if HO is associated with patient outcomes or demographic characteristics. STUDY DESIGN/SETTING: An FDA IDE, prospective, randomized clinical trial was conducted across 23 sites in the United States comparing CDA to ACDF. PATIENT SAMPLE: A total of 164 patients were treated with one-level CDA. OUTCOME MEASURES: Baseline patient demographics collected included age, gender and BMI. Clinical outcome measures included HO, NDI, VAS neck pain and SF-12 PCS. METHODS: Radiographic evaluations were conducted independently through MMI, Inc. Anterior and posterior HO was independently classified using the system adapted from McAfee and Mehren. HO and anteroposterior (AP) endplate lengths were identified using neutral lateral radiographs. The AP prosthesis length was recorded prior to implantation. The AP device position relative to the superior and inferior endplates was used to determine anterior and superior endplate exposure, expressed as a percentage of the total endplate length. Spearman’s rho was used to test for significant correlations. Fisher’s exact test or Mann-Whitney U-test was used to determine significance differences across groups stratified by nonclinically relevant (grades 0, 1 and 2) and clinically relevant (grades 3 and 4) HO. RESULTS: At 60 months, the mean HO grade was 1.8360.92 posteriorly and 1.3161.24 anteriorly (p!0.0001). No significant correlation was found between the posterior HO grade and superior (r50.1457, p50.1008) or inferior (r50.1594, p50.0735) endplate exposure, although inferior endplate exposure demonstrated a trend toward significance. Anterior HO grade was significantly related to both superior (r50.1933, p50.0288) and inferior (r50.3080, p50.0004) endplate exposure; less anterior endplate coverage was correlated to a higher grade of HO at 60 months. Patients with posterior clinically relevant HO showed greater mean endplate exposure at the superior (11.4% vs 9.3%, p50.2197) and inferior endplates (7.6% vs 5.2%, p50.0676)). Compared to patients without clinically relevant HO, endplate exposure for subjects with anterior clinically relevant HO was greater at the superior (7.6% vs 6.7%, p50.9189)) and inferior (9.1% vs 7.6%, p50.8276) endplates. No significant correlation was found between posterior or anterior HO and NDI, VAS Neck, or SF-12 scores. Patient BMI was significantly correlated with both posterior (r50.2390, p50.0021) and anterior (r50.2092, p50.0074) HO; a higher BMI was related to a higher grade of HO. CONCLUSIONS: CDA patient data at five-year follow-up demonstrates a significant relationship between anterior endplate coverage and HO for CDA patients treated at one cervical level. These results suggest that proper device coverage of the endplate may mitigate HO formation. Patients presenting clinically relevant HO showed no significant difference in clinical outcomes at five years. A significant relationship between BMI and HO suggests high BMI as a potential risk factor for HO development. Further study is necessary to understand these relationships. FDA DEVICE/DRUG STATUS: Mobi-C Cervical Disc (Approved for this indication).
http://dx.doi.org/10.1016/j.spinee.2015.07.291 http://dx.doi.org/10.1016/j.spinee.2015.07.292 P56. Heterotopic Ossification and Endplate Coverage in One-Level CDA Patients Pierce D. Nunley, MD1, David A. Cavanaugh, MD1, Eubulus J. Kerr, III, MD1, Andrew Utter, MD1, Kelly Frank, MS2, Marcus Stone, PhD3; 1Spine Institute of Louisiana, Shreveport, LA, US; 2Shreveport, LA, US; 3Spine Institute of Louisiana Foundation, Shreveport, LA, US BACKGROUND CONTEXT: While heterotopic ossification (HO) is a known adverse event for patients treated with cervical disc arthroplasty (CDA), the disease etiology is not fully understood.
P57. Prospective Cost Utility Analysis of Adult Deformity Surgery John A. Sielatycki, MD1, Silky Chotai, MD2, Scott L. Parker, MD3, Matthew J. McGirt, MD4, Clinton J. Devin, MD1, Kevin O’Neill, MD5; 1 Vanderbilt University Medical Center, Nashville, TN, US; 2Nashville, TN, US; 3Vanderbilt University, Nashville, TN, US; 4Carolina Neurosurgery & Spine Associates, Charlotte, NC, US; 5Vanderbilt University Medical Center Department of Orthopaedics, Nashville, TN, US BACKGROUND CONTEXT: There is a paucity of information describing the cost utility of adult spine deformity surgery, which has largely
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.
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Proceedings of the NASS 30th Annual Meeting / The Spine Journal 15 (2015) 87S–267S
relied on retrospective data. There is a need for prospective cost analyses of the cost-utility of adult spinal deformity correction. PURPOSE: To perform a prospective cost per quality adjusted life year (QALY) analysis in adult patients undergoing spinal deformity correction, and to determine if these patients reach the cost-effectiveness threshold (!$100,000 per QALY) by the 2-year postoperative time point. STUDY DESIGN/SETTING: Prospective analysis of adult patients undergoing deformity surgery from 2011-2013 at a single academic institution. PATIENT SAMPLE: Consecutive adult patients undergoing spinal deformity correction were enrolled in a prospective longitudinal registry. Patients with a minimum 2-year follow up were included. Cases of infection, trauma and tumor were excluded. OUTCOME MEASURES: EuroQol-5D (EQ-5D) scores were utilized to calculate quality-adjusted life years. METHODS: Total back-related medical resource utilization, missed work and health state values (QALYs, calculated from EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and workday losses were multiplied by the gross-of-tax wage rate (indirect cost). Mean 2-year QALY gained was assessed using the time weighted area under the curve approach. The mean total 2-year cost/QALY gained was then calculated. RESULTS: There were 51 patients with a mean age of 60 years included. Fusion was performed over an average of 8 levels, and 3-column osteotomies performed in 10 patients (20%). Median length of hospitalization was 5 days. Reoperations within 2 years PO occurred in 8 patients (16%). EQ5D scores improved significantly from baseline (change: 0.13, p!0.01). With a mean total cost of $56,798 (direct cost: $49,455, indirect cost: $7,343) and mean QALY gained of 0.62, the cost/QALY was found to be $91,609 at 2 years PO. CONCLUSIONS: In contrast to previous reports based on retrospective data, this prospective study suggests adult deformity surgery to be cost effective at 2 years PO with a cost/QALY of $91,609. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2015.07.293
P58. Cost per Quality Adjusted Life Years Gained for Anterior Cervical Discectomy and Fusion for Degenerative Spine Disease in Elderly Population Silky Chotai, MD1, Scott L. Parker, MD2, Ahilan Sivaganesan, MD3, Matthew J. McGirt, MD4, Clinton J. Devin, MD3; 1Nashville, TN, US; 2 Vanderbilt University, Nashville, TN, US; 3Vanderbilt University Medical Center, Nashville, TN, US; 4Carolina Neurosurgery & Spine Associates, Charlotte, NC, US BACKGROUND CONTEXT: Anterior cervical decompression and fusion (ACDF) is a most commonly used intervention in patients with myelopathy and radiculopathy. With growing elderly population and increasing rates of spinal surgery in this age group it is vital to understand the value of ACDF in this population. PURPOSE: The aim of the present study was to determine the cost utility following ACDF for myelopathy and radiculopathy in elderly patients. STUDY DESIGN/SETTING: Analysis of prospective longitudinal registry data at a single center. PATIENT SAMPLE: A total of 299 patients undergoing elective ACDF for degenerative cervical pathology over a period of two years were included in the study. OUTCOME MEASURES: Quality of life years (QALY) gained and cost per QALY at 2 years after surgery. Patient-reported outcome (PRO); NDI, numeric rating scale neck and arm pain (NP, AP), general health and quality of life scores via EQ-5D and SF-12 were recorded at baseline, 1-year and 2-years after surgery. METHODS: Patients were divided into age groups (younger) !65 years, and $65 years (older) to compare the QALYs gained and the cost utility in
these age groups. One- and two-year medical resource utilization, missed work and health state values (QALYs), calculated from the EQ-5D with US valuation were assessed using time weighted area under the curve approach. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The direct cost and total cost (direct þ indirect) was used to assess mean total 2-year cost per QALY gained after surgery. RESULTS: There was a significant improvement in pain (NP, AP), disability (NDI) and general health scores (EQ-5D and SF-12) among all age groups 2 years after surgery (P!0.0001). Fifty-two percent (155) of patients underwent ACDF for myelopathy and 48% (144) underwent ACDF for radiculopathy; there was no significant difference in the number of patients with radiculopathy (42% vs 49%) and myelopathy (58% vs 51%) in patients age $65 years (n5263) compared to those ! 65 years (n536). The mean direct costs and total costs at 24-month were $18,828 and $23,579 for younger patients and $19,241and $21,197 for older patients. Younger patients had higher total cost at 24 months due to higher workday losses; direct cost was, however, higher in the older age group which was found to be associated with a higher mean number of co-morbidities (1.5 vs 2.7, P50.02) and mean longer hospital stay (1.2 vs 2.3 days, P50.018). Patients over 65 years old had a 33% preoperative gainful employment compared to 62% patients with age !65 years. There was no statistically significant difference in mean direct cost among the younger and older patients. The younger patients had higher mean cumulative 2-year gain of 0.47 QALYs compared to 0.28 QALYs in older patients. The two-year direct cost-utility and total cost-utility in patients age ! 65 years was $40059 and $50168/QALY compared to $68717/QALY and $75703/QALY in those $ 65 years. CONCLUSIONS: ACDF provided a significant gain in health state utility in elderly patients with degenerative cervical pathology, with a mean cumulative 2-year cost per QALY gained of $75,703/QALY, which can be considered moderately cost-effective as per the threshold of $100,000/QALY gained. Elderly patients did not demonstrate the cost-effectiveness as much as their younger counterparts; however, surgery does provide a clinically meaningful improvement in outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2015.07.294
P59. Cost per Quality Adjusted Life Years Gained of Lumbar Decompression and Fusion for Degenerative Spine Disease: Defining the Value of Surgical Intervention in Elderly Population Clinton J. Devin, MD1, Silky Chotai, MD2, Scott L. Parker, MD3, Lindsay Tetreault4, Michael G. Fehlings, MD, PhD, FRCSC5, Matthew J. McGirt, MD6; 1Vanderbilt University Medical Center, Nashville, TN, US; 2Nashville, TN, US; 3Vanderbilt University, Nashville, TN, US; 4 University of Toronto, Oakville, ON, Canada; 5Toronto Western Hospital, Toronto, ON, Canada; 6Carolina Neurosurgery & Spine Associates, Charlotte, NC, US BACKGROUND CONTEXT: Value-based purchasing and pay-for-performance models are rapidly being implemented to subjugate the unsustainable cost of the US health care system. Cost-utility analysis has emerged as an important tool to determine the value of care and balance the health care costs of patient-centered care with responsible use of societal health care resources. With a growing elderly population and increasing rates of spine surgery, it is vital to understand the value of spinal surgery in this population. PURPOSE: We set forth to determine the cost-effectiveness of lumbar decompression with and without fusion for degenerative spine disease in elderly patients. STUDY DESIGN/SETTING: Analysis of prospective longitudinal registry based data.
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.