A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children and Adolescents with Generalized Anxiety Disorder.

Objective: Generalized anxiety disorder (GAD) in children and adolescents is associated with substantial morbidity and increases the risk of future psychopathology. However, relatively few psychopharmacologic studies have examined treatments for GAD in pediatric populations, especially in prepubertal youth. Methods: Children and adolescents aged 7-17 years of age with a primary diagnosis of GAD were treated with flexibly dosed escitalopram (10-20 mg daily, n = 138) or placebo (n = 137) for 8 weeks. Efficacy measures included the Pediatric Anxiety Rating Scale (PARS) for GAD, Clinical Global Impression of Severity (CGI-S) scale, Children's Global Assessment Scale (CGAS); safety measures included the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as adverse events (AEs), vital signs, and electrocardiographic and laboratory monitoring. Results: Escitalopram was superior to placebo in reducing anxiety symptoms of GAD, as seen in the difference in mean change from baseline to week 8 on the PARS severity for GAD score (least squares mean difference = -1.42; p = 0.028). Functional improvement, as reflected by CGAS score, was numerically greater in escitalopram-treated patients compared with those receiving placebo (p = 0.286), and discontinuation owing to AEs did not differ between the two groups. Vital signs, weight, laboratory, and electrocardiographic results were consistent with previous pediatric studies of escitalopram. Conclusions: Escitalopram reduced anxiety symptoms and was well tolerated in pediatric patients with GAD. These findings confirm earlier reports of escitalopram efficacy in adolescents aged 12-17 years and extend the safety and tolerability data to children with GAD aged 7-11 years. ClinicalTrials.gov Identifier: NCT03924323.

Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion.

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.

Clinical evaluation of an allogeneic bone matrix containing viable osteogenic cells in patients undergoing one- and two-level posterolateral lumbar arthrodesis with decompressive laminectomy.

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.