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BackgroundWith the COVID-19 pandemic disrupting many facets of our society, physicians and patients have begun using telemedicine as a platform for the delivery of health care. One of the challenges in implementing telemedicine for the spine care provider is completing a comprehensive spinal examination. Currently, there is no standardized methodology to complete a full spinal examination through telemedicine.MethodsWe propose a novel, remote spinal examination methodology that is easily implemented through telemedicine, where the patient is an active participant in the successful completion of his or her examination. This type of examination has been validated in a neurology setting. To facilitate the telemedicine visit, we propose that video instruction be shared with the patient prior to the telemedicine visit to increase the efficacy of the examination.ResultsSince the issuance of stay-at-home order across the states, many spine practices around the country have rapidly adopted and increased their telemedicine program to continue provide care for patients during COVID-19 pandemic. At a tertiary academic center in a busy metropolitan area, nearly 700 telemedicine visits were successfully conducted during a 4-week period. There were no remote visits being done prior to the shutdown.ConclusionsImplementation of our proposed remote spinal examination has the potential to serve as a guideline for the spine care provider to efficiently assess patients with spine disease using telemedicine. Because these are only suggestions, providers should tailor examination to each individual patient's needs.Level of evidenceV.Clinical relevanceIt is likely that physicians will incorporate telemedicine into health care delivery services even after the COVID-19 pandemic subsides because of telemedicine's efficiency in meeting patient needs. Using the standard maneuvers provided in our study, spine care providers can perform a nearly comprehensive spine examination through telemedicine. Further studies will be needed to validate the reproducibility and reliability of our methodology.

Background Context: The most commonly used materials used for interbody cages are titanium metal and polymer polyetheretherketone (PEEK). Both of these materials have demonstrated good biocompatibility. A major disadvantage associated with solid titanium cages is their radiopacity, limiting the postoperative monitoring of spinal fusion via standard imaging modalities. However, PEEK is radiolucent, allowing for a temporal assessment of the fusion mass by clinicians. On the other hand, PEEK is hydrophobic, which can limit bony ingrowth. Although both PEEK and titanium have demonstrated clinical success in obtaining a solid spinal fusion, innovations are being developed to improve fusion rates and to create stronger constructs using hybrid additive manufacturing approaches by incorporating both materials into a single interbody device., Purpose: The purpose of this study was to examine the interbody fusion characteristic of a PEEK Titanium Composite (PTC) cage for use in lumbar fusion., Study Design/setting: Thirty-four mature female sheep underwent two-level (L 2 -L 3 and L 4 -L 5 ) interbody fusion using either a PEEK or a PTC cage (one of each per animal). Animals were sacrificed at 0, 8, 12, and 18 weeks post surgery., Materials and Methods: Post sacrifice, each surgically treated functional spinal unit underwent non-destructive kinematic testing, microcomputed tomography scanning, and histomorphometric analyses., Results: Relative to the standard PEEK cages, the PTC constructs demonstrated significant reductions in ranges of motion and a significant increase in stiffness. These biomechanical findings were reinforced by the presence of significantly more bone at the fusion site as well as ingrowth into the porous end plates., Conclusions: Overall, the results indicate that PTC interbody devices could potentially lead to a more robust intervertebral fusion relative to a standard PEEK device in a clinical setting., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Trinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures., Methods: In a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months., Results: At both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates., Conclusions: Patients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material., Trial Registration: Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938.

Purpose: This multicenter clinical study was performed to assess the safety and effectiveness of Trinity Evolution(®) (TE), a viable cellular bone allograft, in combination with a PEEK interbody spacer and supplemental anterior fixation in patients undergoing anterior cervical discectomy and fusion (ACDF)., Methods: In a prospective, multi-center study, 31 patients that presented with symptomatic cervical degeneration at one vertebral level underwent ACDF with a PEEK interbody spacer (Orthofix, Inc., Lewisville, TX, USA) and supplemental anterior fixation. In addition all patients had the bone graft substitute, Trinity Evolution (Musculoskeletal Transplant Foundation, Edison, NJ, USA), placed within the interbody spacer. At 6 and 12 months, radiographic fusion was evaluated as determined by independent radiographic review of angular motion (≤4°) from flexion/extension X-rays combined with presence of bridging bone across the adjacent endplates on thin cut CT scans. In addition other metrics were measured including function as assessed by the Neck Disability Index (NDI), and neck and arm pain as assessed by individual Visual Analog Scales (VAS)., Results: The fusion rate for patients using a PEEK interbody spacer in combination with TE was 78.6 % at 6 months and 93.5 % at 12 months. When considering high risk factors, 6-month fusion rates for patients that were current or former smokers, diabetic, overweight or obese/extremely obese were 70 % (7/10), 100 % (1/1), 70 % (7/10), and 82 % (9/11), respectively. At 12 months, the fusion rates were 100 % (12/12), 100 % (2/2), 100 % (11/11) and 85 % (11/13), respectively. Neck function, and neck/arm pain were found to significantly improve at both time points. No serious allograft related adverse events occurred and none of the 31 patients had subsequent additional cervical surgeries., Conclusions: Patients undergoing single-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without serious allograft-related adverse events.

Background: Trinity Evolution® cellular bone allograft (TE) possesses the osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study is to evaluate the radiographic and clinical outcomes when TE is used as a graft extender in combination with locally derived bone in one- and two-level instrumented lumbar posterolateral arthrodeses., Methods: In this retrospective evaluation, a consecutive series of subject charts that had posterolateral arthrodesis with TE and a 12-month radiographic follow-up were evaluated. All subjects were diagnosed with degenerative disc disease, radiculopathy, stenosis, and decreased disc height. At 2 weeks and at 3 and 12 months, plain radiographs were performed and the subject's back and leg pain (VAS) was recorded. An evaluation of fusion status was performed at 12 months., Results: The population consisted of 43 subjects and 47 arthrodeses. At 12 months, a fusion rate of 90.7 % of subjects and 89.4 % of surgical levels was observed. High-risk subjects (e.g., diabetes, tobacco use, etc.) had fusion rates comparable to normal patients. Compared with the preoperative leg or back pain level, the postoperative pain levels were significantly (p < 0.0001) improved at every time point. There were no adverse events attributable to TE., Conclusions: Fusion rates using TE were higher than or comparable to fusion rates with autologous iliac crest bone graft that have been reported in the recent literature for posterolateral fusion procedures, and TE fusion rates were not adversely affected by several high-risk patient factors. The positive results provide confidence that TE can safely replace autologous iliac crest bone graft when used as a bone graft extender in combination with locally derived bone in the setting of posterolateral lumbar arthrodesis in patients with or without risk factors for compromised bone healing., Trial Registration: Because of the retrospective nature of this study, the trial was not registered.

Background: Cellular bone allograft (CBA) possesses osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study was to assess the safety and effectiveness of CBA in foot and/or ankle arthrodeses., Methods: A prospective, multicenter, open-label clinical trial using CBA was performed. At 6 weeks and at 3, 6, and 12 months, imaging was performed and the subject's pain, function, and quality of life (QOL) status (Visual Analog Scale, American Orthopaedic Foot & Ankle Society Hindfoot Scale, and the Short Form 36) were recorded. The per protocol population consisted of 92 patients at 6 months and 76 patients at 12 months, with 153 and 129 total arthrodeses, respectively., Results: At 6 months, fusion rates were 68.5% for all patients and 81.1% for all joints; at 12 months, rates were 71.1% and 86.8%, respectively. Certain high-risk subjects (eg, with diabetes or obesity) had fusion rates comparable to those of normal patients. Statistically significant improvements in pain, function, and QOL were observed, and fusion correlated with both function and QOL outcomes at 6 and 12 months. There were no adverse events attributable to CBA., Conclusion: Fusion rates using CBA were higher than or comparable to fusion rates with autograft that have been reported in the recent literature, and CBA fusion rates were not adversely affected by several high-risk patient factors. CBA was a safe and effective graft material to achieve fusion in patients with compromised bone healing and may provide an effective autograft replacement for foot and/or ankle arthrodeses., Level of Evidence: Level II, prospective study., (© The Author(s) 2015.)

Despite numerous advances in the development of bone graft substitutes over the past 20 years, iliac crest autograft remains the gold standard for lumbar spinal fusion. However, donor site morbidity associated with the harvesting of iliac crest autograft remains problematic. Acute and chronic pain, prolonged operative time, bleeding, infection, deformity, and nerve and vascular injury still produce significant postoperative morbidity, even in the presence of careful surgical technique. Although allograft circumvents donor site morbidity, the growing number of spinal fusions performed in the United States and worldwide is creating a shortage of cadaver bone acceptable for use. Additionally, the extensive processing and storage of allograft is expensive. Synthetic materials, such as beta-tricalcium phosphate (beta-TCP), have been developed as alternatives to both autograft and allograft. A novel formulation of ultraporous beta-TCP (Vitoss, Orthovita, Malvern, Pa) offers interconnected microporosity, providing it with good wicking and hydrophilic properties. These properties allow the migration of nutrients, growth factors, and osteogenic cells into the ultraporous beta-TCP scaffold, thereby promoting new bone growth and concurrent scaffold resorption. This study presents a retrospective review of 7 patients who underwent anterior (ALIF) or posterior (PLIF) interbody fusion at 12 levels with a 3- to 6-month follow-up. At the patients' last radiographic examination, all 12 levels were solidly fused with interbody grafting material consisting only of allograft plus a combination of ultraporous beta-TCP and venous blood as an extender. Additionally, all 7 patients had segmental pedicle-screw fixation.

Heterotopic ossification following hip surgery occurred in three patients with ankylosing hyperostosis of the spine. No technical difficulty during surgery was encountered in these individuals. The occurrence of this postoperative complication, coupled with the appearance of bony outgrowths at sites of ligament attachment throughout the axial and extra-axial skeleton in patients with ankylosing hyperostosis of the spine, suggests the presence of an underlying ossifying diathesis, diffuse idiopathic skeletal hyperostosis (DISH). A significant number of patients with DISH possess the second segregant series antigen, HLA-B27, a feature they share with individuals with other arthropathies characterized by abundant ossification; this gene may be closely related to one which influences bone formation. The possible association of postoperative heterotopic ossification and ankylosing hyperostosis of the spine indicates that a radiographic examination of the vertebral column in patients undergoing hip surgery may be a useful screening procedure.