P148. A Clinical Comparison of a Cervical Artificial Disc and Anterior Cervical Discectomy and Fusion in a Prospective Randomized Trial: Two-Year Follow-Up

P148. A Clinical Comparison of a Cervical Artificial Disc and Anterior Cervical Discectomy and Fusion in a Prospective Randomized Trial: Two-Year Follow-Up

190S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S These data indicated that additional stability could be gained...

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190S

Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S

These data indicated that additional stability could be gained using a cervical plate with the potential to avoid non-union after the ACDF surgery. The initial compressive load across the graft at implantation was 17 N. The initial load after the plate fixation was 86 (N) and was higher than that in ACDF without plate because of initial pre compression. During the all cervical motions in 6 directions, the load increased in the ACDF surgery without plate. In the plate fixation surgery, the compressive load increment during the cervical motion showed variations. In flexion and rotation, the load decreased. In flexion, the load increased by 6-fold as the plate was not used; in contrast, it decreased to half when the cervical plate was used. CONCLUSIONS: Cervical plate in the ACDF surgery provides stability; however, it may cause stress shielding in the grafted bone. To reduce the adverse effects of the stress shielding, the plate should be placed with pre compression on the graft. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.

CONCLUSIONS: In reference to quality of vertebral body filling, those performed with the curved bone catheter were deemed superior to the straight-catheter not only in total quality, but also in each of the three designated planes. Additionally, the grading rubric used to determine overall adequacy of vertebral body filling could become a standard approach to analyzing the technical success of such procedures. In five of 23 cases, repositioning of the curved catheter allowed PMMA to be applied to parts of the vertebral body that a straight trocar could not reach. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.407

P147. Improving the Adequacy of Vertebral Body Filling in Percutaneous Vertebroplasty Using a Curved Vertebroplasty Needle Avery Evans, MD1, Andrew Pfeffer2, John Gaughen, MD1; 1University of Virginia Health System/School of Medicine, Charlottesville, VA, USA; 2 University of Virginia School of Medicine, Charlottesville, VA, USA

P148. A Clinical Comparison of a Cervical Artificial Disc and Anterior Cervical Discectomy and Fusion in a Prospective Randomized Trial: Two-Year Follow-Up Jeffrey McConnell, MD1, Joseph Marzluff, MD2, Christopher Tomaras, MD3, Ildemaro Volcan, MD4, Allan Goodrich, MD5, Walter Peppelman, Jr., DO6, William Beutler, MD6, Paul L. Asdourian, MD7, Kelly Baker, PhD8; 1 Lehigh Valley Hospital, Allentown, PA, USA; 2Trident Regional Medical Center, North Charleston, SC, USA; 3Peachtree Neurosurgery, Atlanta, GA, USA; 4West Augusta Spine Specialists, Augusta, GA, USA; 5Augusta Orthopaedic Clinic, Martinez, GA, USA; 6Pennsylvania Spine Institute, Harrisburg, PA, USA; 7Union Memorial Hospital, Baltimore, MD, USA; 8 Globus Medical, Audubon, PA, USA

BACKGROUND CONTEXT: Vertebral compression fractures (VCF) typically involve the collapse and compression of the vertebral body. Percutaneous vertebroplasty (PV) with a standard straight trocar is one method to treat this condition. Recently, curved Nitinol bone catheters have been introduced for PV, allowing the operator to reposition the curved catheter in the vertebral body as needed to improve filling. PURPOSE: To evaluate the potential benefits of curved vertebroplasty needles in percutaneous vertebroplasty by analyzing post-operative radiographs for quality of fracture filling in three planes, and the instances of repositioning the curved trocar. STUDY DESIGN/SETTING: Retrospective chart review at UVa Health System Dept. of Radiology. PATIENT SAMPLE: Patients selected underwent PV with PMMA at our institution between 03/2007 and 02/2009. Forty-six cases were studied; 23 consecutive cases involved the use of a curved-tip catheter, 23 consecutive cases during the same time period involved the use of a straight trocar. OUTCOME MEASURES: Adequacy of fracture filling and trocar repositioning were assigned as the primary outcome measures. METHODS: Post-operative AP and lateral radiographs from all 46 cases were de-identified, and randomized. These images were then analyzed to assess the quality of vertebral body filling, as adequate or inadequate, in three planes. In the AP plane, Adequate Fill (AF) was defined as cement reaching the posterior third of the vertebral body as visualized in the lateral film. In the transverse plane, AF was defined as cement fill from the ipsilateral pedicle to the contralateral inner pedicle as seen in the AP film. In the cranial-caudal plane, AF was defined as cement reaching both the superior and inferior endplates as visualized in both the AP and lateral films. Instances of repositioning the curved catheter within the vertebral body were recorded. RESULTS: Quality of Filling per plane: In total, 138 planes of filling were graded by two blinded analysts as either adequate or inadequate based on the qualifications discussed above. Transverse Plane: Observer 1 (OB1) (adequate, inadequate): curved (C) (20, 3), straight (S) (12, 11). OB2: C (19, 3), S (11, 12). AP Plane: OB1: C (20, 3), S (19, 4). OB2: C (18, 5), S (13, 10). Cranial-Caudal Plane: OB1: C (13, 10), S (12, 11). OB2: C (19, 4), S (18, 5). Quality of Filling, total: An overall grade of adequate was attained if at least 2 of 3 the planes were individually assessed as adequate. OB1: C (19, 4), S (16,7). Analysis by paired student’s t-test yields a P 5 0.0829, with CI 5 -0.28 to 0.02. OB2: C (21, 2), S (14, 9). Analysis by paired student’s t-test yields a P 5 0.0052, with CI 5 -0.51 to -0.10. Five of the 23 curved cases were completed with repositioning.

BACKGROUND CONTEXT: While anterior cervical discetomy and fusion (ACDF) provides rigid fixation increasing the likelihood of bony fusion and pain reduction in patients with symptomatic cervical disease, mobility and normal physiological motion can be compromised. Cervical arthroplasty offers height restoration of the degenerated disc, alleviating pain without the associated loss in motion. PURPOSE: The purpose of this study is to investigate the clinical results of traditional ACDF versus a cervical arthroplasty device. STUDY DESIGN/SETTING: A prospective, randomized Investigational Device Exemption (IDE) clinical trial of the SECURE-C Cervical Artificial Disc (Globus Medical, Audubon, PA) is being conducted in the US. The first five patients at all sites were treated with the artificial disc (SEC) and all patients thereafter were randomized 1:1 to either SEC or control ACDF. The ASSURE Cervical Plate (Globus Medical, Audubon, PA) and allograft spacer represented the ACDF group. Multi-site pooled outcomes from 217 patients at 6 centers are reported. PATIENT SAMPLE: Patients with single-level symptomatic cervical disc disease (SCDD) between C3 and C7 defined by neck and/or arm pain, herniated nucleus pulposus, radiculopathy or myelopathy were enrolled. Patients must be between 18 and 60 years of age, complete at least 6 weeks of conservative therapy, and have a Neck Disability Index (NDI) of at least 30/100. The group includes 103 (47%) females and 114 (53%) males. The average age was 43.1 years for SEC patients and 45.0 years for ACDF patients. OUTCOME MEASURES: Outcome measurements include NDI, Visual Analog Scale (VAS) neck and arm pain, SF-36 Health Status Survey, and patient satisfaction. These evaluations are collected pre-operatively and at 6 wk, 3 mo, 6 mo, 1 yr and 2 yr post-operatively. METHODS: Data from six centers having received approval by their Institutional Review Boards is presented. Of the 217 patients, 126 were treated with SECURE-C and 91 received ACDF. Data from 216 patients, with 216 at 6 weeks, 209 at 3 months, 202 at 6 months, 185 at 12 months, and 89 at 2 years post-operative, are analyzed. RESULTS: Both SEC and ACDF groups demonstrated improved pain and function as evidenced through NDI scores (Fig. 1). There was a significant decrease in NDI (SEC: 51.7613.6. ACDF: 53.0614.6) by 6 weeks postoperative (SEC: 18.0617.4, ACDF: 21.1619.3), with a continued reduction up to 2 years (SEC: 9.4615.1, ADCF: 13.0614.0). While there was no significant difference between groups, as a trend, the SEC group had reduced NDI when compared to ACDF. Similar results were witnessed for neck pain VAS with average scores decreasing (SEC: 63.5627.4, ADCF: 65.2627.4) to (SEC: 14.2624.3, ADCF:13.1620.9) after 1 year,

doi: 10.1016/j.spinee.2009.08.406

Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S and (SEC: 10.6622.2, ADCF:17.2624.9) after 2 years. Similarly, SF-36 PCS improved for both groups. Patient satisfaction was over 90% for both patients groups at 2 year post-op. Two ACDF plates were removed; one SECURE-C implant was removed and one SECURE-C patient had another cervical disc implanted at an adjacent level. No device-related complications or events occurred in either treatment group. CONCLUSIONS: While the long-term safety and efficacy of cervical arthroplasty is yet to be determined, one and two year clinical results are promising with comparable results in clinical pain and function scores. SECURE-C appears to provide equivalent pain relief to patients suffering from SCDD without the restrictive loss in motion inherent in ACDF.

Figure.

FDA DEVICE/DRUG STATUS: SECURE-C Cervical Artificial Disc: Investigational/Not approved; ASSURE Cervical Plate: Approved for this indication.

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complete the SRS-22 instrument: 22 questions scaled 1-5(highest). Additional questions were asked to assess household income (low: ! $30 K; middle: $30-125 K; high: O$125 K), race (Caucasian, Hispanic, AfricanAmerican, other), gender, and household status (single versus dual parent). ANOVA and multivariate regression analyses were used to identify which of these factors significantly influenced SRS performance. Adolescents with AIS were asked to complete the SRS-22 pre-operatively during their office visit. Comparisons between healthy adolescents and AIS were done with a t-test. RESULTS: Factors that improved SRS-22 performance included male gender (p!0.0001), dual parent household (p!0.05), and BMI!25 (p!0.0001). Compared with subjects in middle income households, subjects in low and high income households had lower SRS-22 performance outcomes (p!0.05). Race and age did not significantly affect mean SRS22 performance, but African American or Caucasian race did positively influence activity and body image domain scores (p!0.05). Among healthy adolescents, Mean SRS-22 performance was 4.160.5 (Activity: 4.060.6; Pain: 4.360.7; Image: 4.160.7; Mental: 3.860.8). Mean SRS-22 performance for age-matched AIS patients was 3.862.6 (Activity: 4.162.8; Pain: 4.064.0; Image: 3.364.0; Mental: 3.863.3). Overall SRS-22 performance, but more specifically pain and body image domain scores were decreased in AIS compared to healthy adolescents (p!0.001). There was no difference in age distribution between the two groups (p50.84). CONCLUSIONS: We report that BMI!25, male gender, dual parent household, and middle income families had improved overall SRS-22 performance in healthy adolescents. Race and age did not influence overall SRS-22 performance, but did influence activity and body image domain scores. Overall SRS-22 and specifically pain and body image domain scores were significantly decreased in patients with AIS compared to normal healthy adolescents. Our data provides a normative dataset of unaffected adolescents with variable baseline demographic status. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.409

doi: 10.1016/j.spinee.2009.08.408

P149. Demographic Factors Affect SRS-22 Performance in Healthy Adolescents: A Comparative Baseline for Adolescent Idiopathic Scoliosis Kushagra Verma, MS1, Itzhak Engel, MD1, Laura Dean, BA1, Josh Auerbach, MD2, Yael Goldstein, PA-C1, Jane Haoshi, MD1, Baron Lonner, MD1; 1NYU Hospital for Joint Diseases, New York, NY, USA; 2Washington University, St. Louis, MO, USA BACKGROUND CONTEXT: The SRS-22 instrument has been used widely to evaluate patients with scoliosis. However, no study has characterized how demographic factors may influence SRS-22 scores in normal healthy adolescents. Moreover, no comparative baseline of normal unaffected persons exists for patients with adolescent idiopathic scoliosis (AIS). PURPOSE: The purpose of this study was to: 1) evaluate the influence of race, gender, household status, and income on SRS-22 performance and 2) compare SRS-22 performance between normal adolescents without scoliosis and patients with AIS. STUDY DESIGN/SETTING: Prospective analysis using an anonomyous survey; retrospective analysis of prospectively collected data in consecutive patients. PATIENT SAMPLE: 324 healthy unaffected adolescents completed the SRS-22 (54% female, 46% male; mean age was 15.763.3). 58 adolescents with scoliosis completed the SRS-22 before undergoing surgical correction (24% male, 76% female, mean age 16.262.3). OUTCOME MEASURES: Clinical outcomes were individual domain and overall SRS-22 performance. METHODS: Healthy adolescents at a high school health clinic and at the private offices of referring pediatricians were asked to anonymously

P150. An Anatomic Study Correlating the Position of the L5 Vertebral Body with L5/S1 Disc Degeneration: Does a ‘‘Deep Seated’’ L5 Afford Any Protection? Sheeraz Qureshi, MD1, Jason Toy, BS2, Paul Gause, MD3, Ryan Garcia, MD2, Jason Eubanks, MD2, Nicholas Ahn, MD2; 1Mount Sinai School of Medicine, New York, NY, USA; 2Case Western Reserve University, Cleveland, OH, USA; 3Canyon Orthopaedic Surgeons, Ltd. - Phoenix, Avondale, AZ, USA BACKGROUND CONTEXT: Previously, authors have attempted to establish a relationship between the position of the L5 segment relative to the intercristal line and spinal degeneration distal to a fusion stopping at L5. A classification exists defining a deep seated L5 segment as one where the intercristal line passes above the L5 pedicles. The question which arises however, is whether a deep seated L5 has a protective effect on the L5/S1 disk even in subjects that have not undergone fusion. PURPOSE: The purpose of this study was to determine the prevalence of a deep seated L5 in the general population and whether subjects with a deep seated L5 had a decreased incidence of L5-S1 disc degeneration. STUDY DESIGN/SETTING: A cross-sectional, observational study was performed on adult cadaveric specimens with that were randomly selected from the Hamann Todd Collection in the Cleveland Museum of Natural History. This collection houses the dried, disarticulated spines from over 3100 individuals who died in Cleveland, Ohio between the years of 1893-1938. PATIENT SAMPLE: 600 cadaveric specimens with intact lumboscral segments were randomly identified out of 3100 total cadaveric specimens. The age ranged from 20- 80 years of age and included both male and female specimens of various race. Pediatric specimens, specimens in poor