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Ceramic Biologics for Bony Fusion-a Journey from First to Third Generations

Ortega, Brandon; Gardner, Carson; Roberts, Sidney; Chung, Andrew; Wang, Jeffrey C; Buser, Zorica
PURPOSE OF REVIEW/OBJECTIVE:To provide information on characteristics and use of various ceramics in spine fusion and future directions. RECENT FINDINGS/RESULTS:In most recent years, focus has been shifted to the use of ceramics in minimally invasive surgeries or implementation of nanostructured surface modification features to promote osteoinductive properties. In addition, effort has been placed on the development of bioactive synthetics. Core characteristic of bioactive synthetics is that they undergo change to simulate a beneficial response within the bone. This change is based on chemical reaction and various chemical elements present in the bioactive ceramics. Recently, a synthetic 15-amino acid polypeptide bound to an anorganic bone material which mimics the cell-binding domain of type-I collagen opened a possibility for osteogenic and osteoinductive roles of this hybrid graft material. Ceramics have been present in the spine fusion arena for several decades; however, their use has been limited. The major obstacle in published literature is small sample size resulting in low evidence and a potential for bias. In addition, different physical and chemical properties of various ceramics further contribute to the limited evidence. Although ceramics have several disadvantages, they still hold a great promise as a value-based graft material with being easily available, relatively inexpensive, and non-immunogenic.
PMCID:7340712
PMID: 32562147
ISSN: 1935-973x
CID: 5186662

Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review

Jain, Amit; Marrache, Majd; Harris, Andrew; Puvanesarajah, Varun; Neuman, Brian J; Buser, Zorica; Wang, Jeffrey C; Yoon, S Tim; Meisel, Hans Jörg
STUDY DESIGN/UNASSIGNED:Systematic literature review. OBJECTIVE/UNASSIGNED:Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups. METHODS/UNASSIGNED:Through a systematic review of the English-language literature using various databases, we identified 4702 articles. After we applied inclusion and exclusion criteria, 14 articles (7 randomized controlled trials, 4 prospective studies, and 3 retrospective studies) reporting fusion rates of structural allograft or PEEK interbody devices were eligible for our analysis. No randomized controlled trials compared outcomes of structural allograft versus PEEK interbody devices. Extracted data included authors, study years, study designs, sample sizes, patient ages, duration of follow-up, types of interbody devices used, fusion rates, definition of fusion, reoperation rates, subsidence rates, and patient-reported outcomes. RESULTS/UNASSIGNED:Fusion rates were 82% to 100% for allograft and 88% to 98% for PEEK interbody devices. The reported data were insufficient to perform meta-analysis. Structural allograft had the highest reported rate of reoperation (14%), and PEEK interbody devices had the highest reported subsidence rate (18%). Patient-reported outcomes improved in both groups. There was insufficient high-quality evidence to compare the associations of various PEEK modifications with fusion rates. CONCLUSION/UNASSIGNED:Fusion rates were similar between structural allograft and PEEK interbody devices when used for ACDF for cervical spine degeneration. Currently, there is insufficient high-quality evidence to assess associations of PEEK modifications with fusion rates. LEVEL OF EVIDENCE/UNASSIGNED:II.
PMCID:7383799
PMID: 32707023
ISSN: 2192-5682
CID: 5186672

Reliability Statistics: A "Weight-Bearing" View [Letter]

Abedi, Aidin; Lashkari, Nassim; Buser, Zorica; Wang, Jeffrey C
PMCID:7485074
PMID: 32905724
ISSN: 2192-5682
CID: 5186702

Development of AOSpine BOnE (Bone Osteobiologics and Evidence) Classification

Wang, Jeffrey C; Yoon, S Tim; Brodke, Darrel S; Park, Jong-Beom; Hsieh, Patrick; Meisel, Hans-Joerg; Buser, Zorica
STUDY DESIGN/UNASSIGNED:Classification development. OBJECTIVES/UNASSIGNED:The aim of our study was to develop a 3-tier classification for the levels of evidence for osteobiologics and provide a description of the principles by which osteobiologics can be evaluated. BOnE (Bone Osteobiologics and Evidence) classification evaluates each osteobiologic based on the available evidence, and if the published evidence is based on clinical, in vivo or in vitro studies. METHODS/UNASSIGNED:The process of establishing the BOnE classification included 5 face-to-face meetings and 2 web calls among members of the AOSpine Knowledge Forum Degenerative. RESULTS/UNASSIGNED:The 3 levels of evidence were determined based on the type of data on osteobiologics: level A for human studies, level B for animal studies, and level C for in vitro studies, with level A being the highest level of evidence. Each level was organized into 4 subgroups (eg, A1, A2, A3, and A4). CONCLUSIONS/UNASSIGNED:The use and the variety of osteobiologics for spine fusion has dramatically increased over the past few decades; however, literature on their effectiveness is inconclusive. Several prior systematic reviews developed by AOSpine Knowledge Forum Degenerative reported low level of evidence primarily due to the high risk of bias, small sample size, lack of control groups, and limited patient-reported outcomes. BOnE classification will provide a universal platform for research studies and journal publications to classify a new or an existing product and will allow for creating decision-making algorithms for surgical planning.
PMCID:7485069
PMID: 32905732
ISSN: 2192-5682
CID: 5186712

Examination of the Role of Cells in Commercially Available Cellular Allografts in Spine Fusion: An in Vivo Animal Study

Abedi, Aidin; Formanek, Blake; Russell, Nicholas; Vizesi, Frank; Boden, Scott D; Wang, Jeffrey C; Buser, Zorica
BACKGROUND:Despite the extensive use of cellular bone matrices (CBMs) in spine surgery, there is little evidence to support the contribution of cells within CBMs to bone formation. The objective of this study was to determine the contribution of cells to spinal fusion by direct comparisons among viable CBMs, devitalized CBMs, and cell-free demineralized bone matrix (DBM). METHODS:Three commercially available grafts were tested: a CBM containing particulate DBM (CBM-particulate), a CBM containing DBM fibers (CBM-fiber), and a cell-free product with DBM fibers only (DBM-fiber). CBMs were used in viable states (CBM-particulatev and CBM-fiberv) and devitalized (lyophilized) states (CBM-particulated and CBM-fiberd), resulting in 5 groups. Viable cell counts and bone morphogenetic protein-2 (BMP-2) content on enzyme-linked immunosorbent assay (ELISA) within each graft material were measured. A single-level posterolateral lumbar fusion was performed on 45 athymic rats with 3 lots of each product implanted into 9 animals per group. After 6 weeks, fusion was assessed using manual palpation, micro-computed tomography (μ-CT), and histological analysis. RESULTS:The 2 groups with viable cells were comparable with respect to cell counts, and pairwise comparisons showed no significant differences in BMP-2 content across the 5 groups. Manual palpation demonstrated fusion rates of 9 of 9 in the DBM-fiber specimens, 9 of 9 in the CBM-fiberd specimens, 8 of 9 in the CBM-fiberv specimens, and 0 of 9 in both CBM-particulate groups. The μ-CT maturity grade was significantly higher in the DBM-fiber group (2.78 ± 0.55) compared with the other groups (p < 0.0001), while none of the CBM-particulate samples demonstrated intertransverse fusion in qualitative assessments. The viable and devitalized samples in each CBM group were comparable with regard to fusion rates, bone volume fraction, μ-CT maturity grade, and histological features. CONCLUSIONS:The cellular component of 2 commercially available CBMs yielded no additional benefits in terms of spinal fusion. Meanwhile, the groups with a fiber-based DBM demonstrated significantly higher fusion outcomes compared with the CBM groups with particulate DBM, indicating that the DBM component is probably the key determinant of fusion. CLINICAL RELEVANCE/CONCLUSIONS:Data from the current study demonstrate that cells yielded no additional benefit in spinal fusion and emphasize the need for well-designed clinical studies on cellular graft materials.
PMID: 33079897
ISSN: 1535-1386
CID: 5186742

The incidence of myocardial infarction after lumbar spine surgery

Harwin, Brett; Formanek, Blake; Spoonamore, Mark; Robertson, Djani; Buser, Zorica; Wang, Jeffrey C
PURPOSE/OBJECTIVE:As the population continues to age, the number of lumbar spine surgeries continues to increase. While there are many complications associated with lumbar surgeries, a myocardial infarction (MI) is a particularly devastating one. This complication is of considerable importance with mortality rates of postoperative MI documented between 26.5 and 70%. This study aimed to determine the relationship between lumbar surgeries, preoperative diagnoses (risk factors), and myocardial infarction. METHODS:Data from the Humana database (PearlDiver) were analyzed from 2007 to 2016. Patients undergoing lumbar spine surgeries were identified and stratified based on procedural approach, patient demographics, and preoperative risk factors. Each group was analyzed to determine the incidence and relative risk. Chi-square analysis was used to determine the significance. RESULTS:A total of 105,505 patients who fit inclusion criteria were identified in the PearlDiver database between 2007 and 2016. A total of 644 patients (0.63%) experienced a postoperative myocardial infarction within 30 days of surgery. Patients undergoing fusion and non-fusion procedures showed significantly different rates of postoperative myocardial infarction (0.08% vs. 0.05%, p < 0.01). Male patients, older patients, and patients with a Charlson comorbidity index > 3 showed a considerable increase in incidence (p < 0.01). Furthermore, patients with preoperative risk factors (high cholesterol, obesity, depression, congestive heart failure, hypertension, and hypotension) exhibited risk ratios from 0.01 to 1.85 (p < 0.01). CONCLUSION/CONCLUSIONS:Preoperative risk factors, patient demographics, and procedure type had a significant effect on the incidence of postoperative myocardial infarction. These slides can be retrieved under Electronic Supplementary Material.
PMID: 31325049
ISSN: 1432-0932
CID: 5186542

Performance properties of health-related measurement instruments in whiplash: systematic review protocol

Abedi, Aidin; Prinsen, C A C; Shah, Ishan; Buser, Zorica; Wang, Jeffrey C
BACKGROUND:Whiplash is a common traumatic cervical injury which is most often a consequence of rear-end motor vehicle accidents. It has been estimated that up to 50% of the whiplash patients suffer from chronic symptoms, resulting in extensive individual and societal burden. Several measurement instruments are used for initial assessment of whiplash and evaluation of response to treatment. However, a comprehensive assessment of the performance of these measures is lacking. Furthermore, there is no consensus on the most relevant outcome domains and their corresponding measurement instruments of choice. This systematic review aims to identify, describe, and critically appraise the performance properties of health-related measurement instruments in whiplash population. METHODS:The following literature databases will be searched from their date of establishment: PubMed, Embase®, MEDLINE, CINAHL Complete, PsycINFO, and HAPI. All original articles evaluating the reliability, validity, responsiveness, and feasibility of health-related measurement instruments in whiplash will be included, without additional restriction on their intended use, source of data, and structure. Risk of bias will be assessed using the COSMIN Risk of Bias checklist. Findings of the studies will be judged against the criteria for good measurement properties, and results from all studies will be qualitatively summarized to generate an overall quality of findings. Overall quality of evidence will be determined using a modified GRADE approach, which will be used in conjunction with the overall quality of results for generation of recommendations. Two reviewers will perform all steps of the review independently. Discrepancies will be discussed between the reviewers, and in case of remaining disagreement, the senior reviewer will make the final decision. DISCUSSION:This systematic review will summarize the body of literature on health-related measurement instruments in whiplash, aiming to facilitate the selection of high-quality measurement instrument for researchers and physicians. Findings of this study will guide the ongoing efforts for development of a core outcome set. SYSTEMATIC REVIEW REGISTRATION:PROSPERO reference number CRD42018070901.
PMCID:6688369
PMID: 31399055
ISSN: 2046-4053
CID: 5186552

The DOWN Questionnaire: A Novel Screening Tool for Cervical Spondylotic Myelopathy

Barkoh, Kaku; Ohiorhenuan, Ifije E; Lee, Larry; Lucas, Joshua; Arakelyan, Anush; Ornelas, Christopher; Buser, Zorica; Hsieh, Patrick; Acosta, Frank; Liu, John; Wang, Jeffrey C; Hah, Raymond
Study Design/UNASSIGNED:Case-control study. Objectives/UNASSIGNED:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord injury in adults aged over 55 years. However, since the onset is typically insidious, accurately diagnosing CSM can be challenging, often requiring referral to a subspecialist and advanced imaging. To help identify patients at risk for CSM, this case-control study compared responses to a series of 4 questions (DOWN questionnaire) in myelopathic and non-myelopathic patients. Methods/UNASSIGNED:Ninety-two patients, 46 with and 46 without myelopathy, were recruited for the study. Each patient answered 4 questions encompassing common symptoms associated with CSM. Responses between patient groups were compared, and Cohen's κ was used to assess for agreement between responses and the diagnosis of myelopathy. Results/UNASSIGNED:We found a sensitivity of 91% and a κ of 0.54 to 3 positive responses and a sensitivity of 72% and a κ of 0.61 to 4 positive responses. Conclusions/UNASSIGNED:Positive responses to 3 or more DOWN questions has high sensitivity and moderate agreement with the diagnosis of myelopathy based on history, physical exam, and review of advanced imaging by an orthopedic or neurological surgeon. The DOWN questionnaire is a potentially useful screening tool to identify patients at risk for CSM.
PMCID:6693067
PMID: 31448193
ISSN: 2192-5682
CID: 5186582

Answer to the Letter to the Editor of T. Imamura concerning "The incidence of myocardial infarction after lumbar spine surgery" by Harwin B, Formanek B, Spoonamore M, Robertson D, Buser Z, Wang JC (Eur Spine J. 2019; doi:10.1007/s00586-019-06072-4) [Comment]

Harwin, Brett; Formanek, Blake; Spoonamore, Mark; Robertson, Djani; Buser, Zorica; Wang, Jeffrey C
PMID: 31444608
ISSN: 1432-0932
CID: 5186572

Trends and Complications in Open Versus Endoscopic Carpal Tunnel Release in Private Payer and Medicare Patient Populations

Devana, Sai K; Jensen, Andrew R; Yamaguchi, Kent T; D'Oro, Anthony; Buser, Zorica; Wang, Jeffrey C; Petrigliano, Frank A; Dowd, Casimir
PMCID:6760088
PMID: 29322873
ISSN: 1558-9455
CID: 5186172