Proceedings of the 34th Annual Meeting of the North American Spine Society / The Spine Journal 19 (2019) S101−S140
S123
AEs in the control group were associated with increasing low back pain. Fifteen (8.3%) IPD and 34 (35.1%) control patients experienced a treatment-related serious AE. Twenty (11.0%) IPD patients had secondary surgery and 10 (10.3%) control patients had treatment surgery at the index level. After 6 months of nonoperative treatment, control patients had the option to crossover to IPD: 57 (58.8%) control patients had crossed over by 24 months. CONCLUSIONS: These analyses support the superiority of this IPD over conservative care for moderate back pain in appropriately selected patients. FDA DEVICE/DRUG STATUS: DIAMTM Spinal Stabilization System (Investigational/Not approved)
central core to incorporate as a single implant suitable for intervertebral fusion. FDA DEVICE/DRUG STATUS: Unavailable from authors at time of publication.
https://doi.org/10.1016/j.spinee.2019.05.265
252. Incidence of PJK with pedicle screws at upper instrumented vertebrae in posterior spinal fusion for adolescent idiopathic scoliosis Yoji Ogura, MD1, Steven D. Glassman, MD1, Daniel J. Sucato, MD2, Michael T. Hresko, MD3, Leah Y. Carreon, MD, MSc1; 1 Norton Leatherman Spine Center, Louisville, KY, US; 2 Texas Scottish Rite Hospital for Children, Dallas, TX, US; 3 Children Hospital Boston, Boston, MA, US
251. Additive manufactured Ti-6Al-4V/polyetheretherketone composite porous cage for interbody fusion: bone growth and biocompatibility evaluation in a porcine model Meng Huang Wu, MD1, Pei-I Tsai, PhD2, TzuHung Lin, PhD2, Jane S. Tsai, PhD3, Ming-Hsueh Lee, MD4, Chih-Yu Chen, MD, PhD5; 1 Department of Orthopedics, Taipei Medical University Hospital, Taipei City, Taiwan; 2 Industrial Technology Research Institute, Hsinchu, Taiwan; 3 ITRI, HsinChu City, Taiwan; 4 Changn Gung Memorial Hospital, Chiayi, Pu Tz City, Taiwan; 5 Shuang-Ho Hospital, New Taipei City, Taiwan BACKGROUND CONTEXT: Several materials have been used to manufacture the cages, the most common being polyetheretherketone (PEEK) and titanium (Ti) alloy (Ti−6Al−4V). Each material has its advantages and disadvantages. PURPOSE: The purpose is to utilize the advantages of each material in combination with additive manufacturing technology to develop a new porous Ti alloy/PEEK composite interbody cage. STUDY DESIGN/SETTING: In vitro mechanical tests and cell biocompatibility study; in vivo posterior instrumented interbody fusion porcine model. PATIENT SAMPLE: In vitro cell culture analysis for Porous Ti alloy/ PEEK composite cages. In vivo animal study used 20 female pigs through an anterior intervertebral lumbar fusion and posterior pedicle screws augmentation. Each level was randomly implanted with one of five testing cages. OUTCOME MEASURES: In vitro mechanical tests for shear strength of the interface layer. In vitro cell culture analysis for alkaline phosphatase (ALP) activity, ALP and osteocalcin mRNA expression for in vitro study. Micro−computed tomography (CT), back-scattered-electrons SEM (BSESEM) and histological analyses for in vivo study. METHODS: In vitro and in vivo study compared 5 groups of cages. The first was a commercialized pure PEEK cage (group 1). The second was a Ti alloy/PEEK composite cage with nonporous Ti alloy end plates (group 2). The third, fourth, and fifth groups were composite cages with porosity of 40%, 60%, and 80% (groups 3, 4, and 5), respectively. Mechanical tests, alkaline phosphatase activity and mRNA expression, osteocalcin mRNA expression, SEM were performed for in vitro study. Micro−computed tomography (CT), back-scattered-electrons SEM (BSE-SEM) and histological analyses were performed for in vivo study. RESULTS: The shear strength reached 33.4 MPa at the Ti alloy/PEEK interface. ALP activity and ALP mRNA expression were positively correlated with the porosity rate and peaked at 60% porosity. Micro-CT and BSE-SEM demonstrated that structures with high porosities, especially 60% and 80%, facilitated more bone formation inside the implant but not outside the implants. Histological analysis also showed that bone formation was better in Ti alloy groups than in the PEEK group. CONCLUSIONS: In vitro cell culture showed higher porous structure exhibited superior bone growth. Micro-CT and histological analyses showed improved bone growth in high-porosity composite cage groups. Composite cage implant takes the biological advantages of Ti alloy porous end plates and the mechanical and radiographic advantages of PEEK
https://doi.org/10.1016/j.spinee.2019.05.266
Friday, September 27, 2019 1:00 − 2:30 PM Spinal Deformity VI
BACKGROUND CONTEXT: Posterior spinal fusion (PSF) using allpedicle screw constructs has become the standard surgical treatment for adolescent idiopathic scoliosis (AIS). However, some studies have shown that all-pedicle screw constructs or the use of pedicle screws at the upper instrumented vertebrae (UIV) increases the incidence of proximal junctional kyphosis (PJK). The purpose of this study is to examine the impact of different instrumentation types on the incidence of PJK following PSF for AIS. PURPOSE: To determine if all-pedicle screw constructs increase the incidence of PJK following PSF for AIS, as pedicle screw placement at the UIV may violate the supra-adjacent facet capsules. STUDY DESIGN/SETTING: Longitudinal cohort study. PATIENT SAMPLE: Multicenter database of surgically treated AIS. OUTCOME MEASURES: PJA. METHODS: A multicenter database of surgically treated AIS was used. A stratified random sampling was done to obtain a representative sample from all curve types. Patients were included if they underwent PSF, and if immediate postoperative and final follow-up radiographs were available. The patients were grouped by instrumentation type: all-pedicle screw (PS), hook at UIV with distal all-pedicle screw (HT), and hybrid (HB). PJA was measured as the angle between UIV and UIV+2 on lateral full-length standing radiographs immediately postoperative and at the final follow-up. PJK was defined as PJA ≥ 10˚ or PJA progression of ≥ 10˚ at the final follow-up. RESULTS: The PS, HT and HB groups included 128, 111 and 106 patients, respectively. There was no difference in baseline demographic and radiographic characteristics among the groups. Fifteen cases (4.3%) developed PJK at the latest follow-up (average 2.2 years). PJK was more common in the PS group (p<0.000), with 14 (11%) in the PS group, 1 (1%) in the HB group, and none in the HT group. No revision surgery was required during the follow-up period. CONCLUSIONS: The incidence of PJK following PSF for AIS was 4.3% and was more common in an all-pedicle screw constructs compared to hybrid or UIV-hook distal pedicle screw constructs. Using hooks at UIV might be a treatment strategy to limit PJK. FDA DEVICE/DRUG STATUS: Unavailable from authors at time of publication. https://doi.org/10.1016/j.spinee.2019.05.267
253. Factors associated with chronic opioid use in preoperative opioid nonusers following adult spinal deformity surgery Andrew B. Harris, BS1, Brian J. Neuman, MD2, Alexandra Soroceanu, MD, MPH3, Richard A. Hostin Jr., MD4, Themistocles S. Protopsaltis, MD5, Peter G. Passias, MD6, Jeffrey L. Gum, MD7, Munish C. Gupta,
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.