While studies support the notion that MSC therapy has a positive effect on OA patients, there is limited high quality evidence and long-term follow-up. The present study summarizes the specifics of high level evidence studies and identifies a lack of consistency, including a diversity of MSC preparations, and thus a lack of reproducibility amongst these articles' methods.
Introduction:Recombinant human bone morphogenetic protein-2 (rhBMP-2) is one of the most commonly used osteogenic agents in the craniofacial skeleton. This study reviews the safety and efficacy of rhBMP-2 as applied to craniofacial reconstruction and assesses the level of scientific evidence currently available.Methods:An extensive literature search was conducted. Randomized controlled trials (RCTs), case series and reports in the English language as well as Food and Drug Administration reports were reviewed. Studies were graded using the Oxford Center for Evidence-Based Medicine Levels of Evidence Scale. Data heterogeneity precluded quantitative analysis.Results:Seventeen RCTs (Levels of evidence: Ib-IIb) were identified evaluating the use of rhBMP-2 in maxillary sinus, alveolar ridge, alveolar cleft, or cranial defect reconstruction (sample size: 7–160; age: 8–75 years). Study designs varied in rigor, with follow-up ranging 3–36 months, and outcome assessment relying on clinical exam, radiology, and/or histology. There was wide variation in rhBMP-2 concentrations, carriers, and controls. Most studies evaluating rhBMP-2 for cranial defect closure, mandibular reconstruction, or distraction osteogenesis consisted of retrospective cohorts and case reports. The evidence fails to support RhBMP-2 use in maxillary sinus wall augmentation, calvarial reconstruction, mandibular reconstruction, or distraction osteogenesis. RhBMP-2 may be effective in alveolar reconstruction in adults, but is associated with increased postoperative edema.Conclusions:A risk–benefit ratio favoring rhBMP-2 over alternative substitutes remains to be demonstrated for most applications in plastic and reconstructive surgery. Long-term data on craniofacial growth is lacking, and using rhBMP-2 in patients younger than 18 years remains off-label.
Background:Face transplant (FT) candidates present with unique anatomic and functional defects unsuitable for autologous reconstruction, making the accurate design and transplantation of patient-specific allografts particularly challenging. In this case series, we present our computerized surgical planning (CSP) protocol for FT.Methods:CSP, computer-aided design and manufacturing, intraoperative navigation, and intraoperative computerized tomography have been successfully incorporated into a comprehensive protocol. Three consecutive FTs were performed. CSP and postoperative results were compared using computerized tomography–derived cephalometric measurements, and the literature was reviewed.Results:Two full and 1 partial FT were successfully performed using the CSP protocol. CSP facilitated the execution of FT with minor angular and translational cephalometric variations on immediate postoperative imaging. Our evolving experience was accompanied by a decreased reliance on cadaveric simulation, from 10 mock transplants and a research procurement before the senior author’s first clinical FT (2012) to 6 mock transplants and no research procurement before the third FT (2018). Operative time was significantly reduced from 36 to 25 hours, as was the need for major orthognathic surgical revision. This reflects the learning curve and variable case complexity, but it is also representative of improved planning and execution, complemented by the systematic incorporation of CSP into FT.Conclusions:A CSP protocol allows for refinement of operative flow, technique, and outcomes in partial and full FT. Standards for functional and esthetic outcomes are bound to evolve with the field’s growth, and computerized planning and execution offer a reproducible approach to FT through objective quality assurance.
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