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A Review of Randomized Controlled Trials in Cleft and Craniofacial Surgery
Bekisz, Jonathan M; Fryml, Elise; Flores, Roberto L
This study presents a systematic review of randomized controlled trials (RCTs) in cleft and craniofacial surgery. All studies reporting on RCTs in cleft and craniofacial surgery were identified on PubMed using the search terms "cleft," "velopharyngeal insufficiency," "velopharyngeal dysfunction," "nasoalveolar molding," "gingivoperiosteoplasty," "Pierre Robin sequence," "craniofacial," "craniosynostosis," "craniofacial microsomia," "hemifacial microsomia," "hypertelorism," "Le Fort," "monobloc," "distraction osteogenesis," "Treacher Collins," and "Goldenhar." Studies were excluded if they were not randomized, did not focus primarily on topics related to cleft or craniofacial surgery, included repeat publications of data, or were unavailable in English. Studies were evaluated on demographic and bibliometric data, study size, specific area of focus, and findings reported. Four hundred forty-seven unique studies were identified. One hundred eighty-three papers met inclusion criteria (115 cleft lip and palate, 65 craniofacial, and 3 spanning both disciplines). Sixty-six (36%) were dedicated to topics related to surgical techniques. There were no studies comparing current cleft lip or soft palate repair techniques and no studies on cleft rhinoplasty. The most frequently reported surgical topic was cleft palate. There were several studies on orthognathic techniques which compared distraction osteogenesis to traditional advancement. Most craniofacial operations, such as cranial vault remodeling and frontofacial advancement/distraction, were not represented. Several standard operations in cleft and craniofacial surgery are not supported by Level I evidence from randomized controlled trials. Our community should consider methods by which more RCTs can be performed, or redefine the acceptable standards of evidence to guide our clinical decisions.
PMID: 29084117
ISSN: 1536-3732
CID: 2765962
Histo-morphologic characteristics of intra-osseous implants of WE43 Mg alloys with and without heat treatment in an in vivo cranial bone sheep model
Torroni, Andrea; Xiang, Chongchen; Witek, Lukasz; Rodriguez, Eduardo D; Flores, Roberto L; Gupta, Nikhil; Coelho, Paulo G
WE43 Mg alloy, composed of Mg, Yttrium, Rare Earth elements, and Zirconium, has proved to be a suitable candidate for production of resorbable osteosynthesis implants in both clinical and experimental settings. In a previous study we tested biocompatibility and degradation properties of untreated (as-cast) and artificially aged (T-5) WE43 Mg-alloys as subperiosteal implants on a maxillofacial sheep model. Both the alloy compositions showed excellent biocompatibility, however, with respect to degradation rate, the as-cast form showed increased degradability compared with the T-5. In the present study, we tested the same alloy composition (i.e. as-cast and T-5) to assess their biological behavior and degradation pattern when implanted as endosteal implants on a calvarial bone sheep model. Six implants in form of cylindrical discs were tested in 6 sheep, one per composition of each disc was placed in two monocortical cranial defect created with high speed trephine bur in the parietal bone. After euthanasia at 6 weeks histomorphological analysis of the bone/implant specimens was performed. WE43-as cast showed higher degradation rate, increased bone remodeling, gas pockets formation and osteolysis compared with the T5 alloy. WE43-T5 showed greater bone/implant interface stability, and seemed to be more suitable for fabrication of endosteal bone screws.
PMID: 29398208
ISSN: 1878-4119
CID: 2947982
Three dimensionally printed bioactive ceramic scaffold osseoconduction across critical-sized mandibular defects
Lopez, Christopher D; Diaz-Siso, J Rodrigo; Witek, Lukasz; Bekisz, Jonathan M; Cronstein, Bruce N; Torroni, Andrea; Flores, Roberto L; Rodriguez, Eduardo D; Coelho, Paulo G
BACKGROUND:Vascularized bone tissue transfer, commonly used to reconstruct large mandibular defects, is challenged by long operative times, extended hospital stay, donor-site morbidity, and resulting health care. 3D-printed osseoconductive tissue-engineered scaffolds may provide an alternative solution for reconstruction of significant mandibular defects. This pilot study presents a novel 3D-printed bioactive ceramic scaffold with osseoconductive properties to treat segmental mandibular defects in a rabbit model. METHODS:Full-thickness mandibulectomy defects (12 mm) were created at the mandibular body of eight adult rabbits and replaced by 3D-printed ceramic scaffold made of 100% β-tricalcium phosphate, fit to defect based on computed tomography imaging. After 8 weeks, animals were euthanized, the mandibles were retrieved, and bone regeneration was assessed. Bone growth was qualitatively assessed with histology and backscatter scanning electron microscopy, quantified both histologically and with micro computed tomography and advanced 3D image reconstruction software, and compared to unoperated mandible sections (UMSs). RESULTS:Histology quantified scaffold with newly formed bone area occupancy at 54.3 ± 11.7%, compared to UMS baseline bone area occupancy at 55.8 ± 4.4%, and bone area occupancy as a function of scaffold free space at 52.8 ± 13.9%. 3D volume occupancy quantified newly formed bone volume occupancy was 36.3 ± 5.9%, compared to UMS baseline bone volume occupancy at 33.4 ± 3.8%, and bone volume occupancy as a function of scaffold free space at 38.0 ± 15.4%. CONCLUSIONS:3D-printed bioactive ceramic scaffolds can restore critical mandibular segmental defects to levels similar to native bone after 8 weeks in an adult rabbit, critical sized, mandibular defect model.
PMCID:5812371
PMID: 29433862
ISSN: 1095-8673
CID: 2956942
Inconsistency in Automated Reports of Scientific Productivity and Impact in Academic Plastic Surgery
Plana, Natalie M; Massie, Jonathan P; Bekisz, Jonathan M; Fryml, Elise M; Spore, Stuart; Diaz-Siso, J Rodrigo; Flores, Roberto L
BACKGROUND:Currently, no consensus metric for measuring academic productivity within plastic surgery exists. The h-index is widely used, as it captures both the quantity and quality of an individual's contribution. However, discrepancies in online reporting make accurate h-index calculation challenging. This study highlights inconsistencies within plastic surgery by assessing differences in reporting of the h-index and other measures of academic productivity across online scientific databases. METHODS:Plastic surgery faculty at institutions with Accreditation Council for Graduate Medical Education-accredited residency programs were identified and searched across four databases: Web of Science, Scopus, Google Scholar, and the National Library of Medicine (PubMed). The total number of publications, citations, and h-index were recorded for each author and analyzed using a Mann-Whitney test. RESULTS:Seven hundred twenty-two faculty members were included in this study. Reporting of publications was highest in Google Scholar and lowest in Web of Science. Because of incomplete information (PubMed) and underuse (Google Scholar), h-index could be assessed only between Web of Science and Scopus, where the average discrepancy in citations and h-index was 722 and 7.0 per author, respectively. Discrepancies were more significant among faculty members holding a Ph.D. degree, higher academic rank, or belonging to the male gender. CONCLUSIONS:Inconsistencies between online scientific databases profoundly affect plastic surgeons. Given the importance placed on metrics such as the h-index, it is imperative that the plastic surgery community push for solutions that ensure more reliable, transparent, and cohesive reporting of academic productivity.
PMID: 29485578
ISSN: 1529-4242
CID: 2965502
Dipyridamole enhances osteogenesis of three-dimensionally printed bioactive ceramic scaffolds in calvarial defects
Bekisz, Jonathan M; Flores, Roberto L; Witek, Lukasz; Lopez, Christopher D; Runyan, Christopher M; Torroni, Andrea; Cronstein, Bruce N; Coelho, Paulo G
PURPOSE/OBJECTIVE:The objective of this study was to test the osteogenic capacity of dipyridamole-loaded, three-dimensionally printed, bioactive ceramic (3DPBC) scaffolds using a translational, skeletally mature, large-animal calvarial defect model. MATERIALS AND METHODS/METHODS:Custom 3DPBC scaffolds designed to present lattice-based porosity only towards the dural surface were either coated with collagen (control) or coated with collagen and immersed in a 100 μM concentration dipyridamole (DIPY) solution. Sheep (n = 5) were subjected to 2 ipsilateral trephine-induced (11-mm diameter) calvarial defects. Either a control or a DIPY scaffold was placed in each defect, and the surgery was repeated on the contralateral side 3 weeks later. Following sacrifice, defects were evaluated through microcomputed tomography and histologic analysis for bone, scaffold, and soft tissue quantification throughout the defect. Parametric and non-parametric methods were used to determine statistical significance based on data distribution. RESULTS:No exuberant or ectopic bone formation was observed, and no histologic evidence of inflammation was noted within the defects. Osteogenesis was higher in DIPY-coated scaffolds compared to controls at 3 weeks (p = 0.013) and 6 weeks (p = 0.046) in vivo. When bone formation was evaluated as a function of defect radius, average bone formation was higher for DIPY relative to control scaffolds at both time points (significant at defect central regions at 3 weeks and at margins at 6 weeks, p = 0.046 and p = 0.031, respectively). CONCLUSION/CONCLUSIONS:Dipyridamole significantly improves the calvarial bone regeneration capacity of 3DPBC scaffolds. The most significant difference in bone regeneration was observed centrally within the interface between the 3DPBC scaffold and the dura mater.
PMCID:5803375
PMID: 29292126
ISSN: 1878-4119
CID: 2899422
Three-Dimensional Soft Tissue Nasal Changes After Nasoalveolar Molding and Primary Cheilorhinoplasty in Infants With Unilateral Cleft Lip and Palate
Mancini, Laura; Gibson, Travis L; Grayson, Barry H; Flores, Roberto L; Staffenberg, David; Shetye, Pradip R
OBJECTIVE:To quantify 3-dimensional (3D) nasal changes in infants with unilateral cleft lip with or without cleft palate (UCL±P) treated by nasoalveolar molding (NAM) and cheilorhinoplasty and compare to noncleft controls. DESIGN/METHODS:Retrospective case series of infants treated with NAM and primary cheilorhinoplasty between September, 2012 and July, 2016. Infants were included if they had digital stereophotogrammetric records at initial presentation (T1), completion of NAM (T2), and following primary cheilorhinoplasty (T3). Images were oriented in 3dMD Vultus software, and 16 nasolabial points identified. PATIENTS/METHODS:Twenty consecutively treated infants with UCL±P. INTERVENTIONS/METHODS:Nasoalveolar molding and primary cheilorhinoplasty. MAIN OUTCOME MEASURES/METHODS:Anthropometric measures of nasal symmetry and morphology were compared in the treatment group between time points using paired Student t tests. Postsurgical nasal morphology was compared to noncleft controls. RESULTS:Nasal tip protrusion increased, and at T3 was 2.64 mm greater than noncleft controls. Nasal base width decreased on the cleft side by 4.01 mm after NAM and by 6.73 mm after cheilorhinoplasty. Columellar length of the noncleft to cleft side decreased from 2:1 to 1:1 following NAM. Significant improvements in subnasale, columella, and nasal tip deviations from midsagittal plane were observed. Treatment improved symmetry of the alar morphology angle and the nasal base-columella angle between cleft and noncleft sides. CONCLUSIONS:Three-dimensional analysis of UCL±P patients demonstrated significant improvements in nasal projection, columella length, nasal symmetry, and nasal width. Compared to noncleft controls, nasal form was generally corrected, with overcorrection of nasal tip projection, columella angle, and outer nasal widths.
PMID: 29698115
ISSN: 1545-1569
CID: 3053152
Resection of Nasal Glial Heterotopia Using a Nasal Subunit Approach
Friel, Michael T; Flores, Roberto L
Background/UNASSIGNED:In the subunit principle of nasal reconstruction, the valleys and low ridges of the nose are designated as topographic subunits. Surgical scars can be located at the borders of subunits to hide their appearance. Case Report/UNASSIGNED:A 30-month-old female presented with an obstructing nasal glial heterotopia (nasal glioma). Using the nasal subunit approach, the mass was exposed using an incision along the subunit borders of the nose. The nasal glioma was completely resected, and the internal nasal valve and the deformed lower lateral cartilages were reconstructed through the subunit approach access incision. The final scar was placed along the subunit borders of the nose. At 6-month follow-up, the patient demonstrated no airway obstruction, adequate nasal contour, and an esthetic nasal scar. Conclusion/UNASSIGNED:The subunit approach for a large, obstructing nasal glial heterotopia allows direct exposure for tumor resection, framework reconstruction, placement of the incision in an esthetic location, and excision of the expanded skin for recontouring of the skin envelope.
PMCID:6135286
PMID: 30258301
ISSN: 1524-5012
CID: 3315772
Cephalometric Predictors of Clinical Severity in Treacher Collins Syndrome
Esenlik, Elcin; Plana, Natalie M; Grayson, Barry H; Flores, Roberto L
BACKGROUND: The aim of this study is to identify cephalometric measurements associated with clinical severity in patients with Treacher Collins Syndrome (TCS). METHODS: A retrospective single-institutional review of patients with TCS was conducted. Pre-operative cephalograms and computed tomography scans (n=30) were evaluated. 50 cephalometric measurements were compared to age-specific normative data using ANOVA. These cephalometric measurements and the patient's Pruzansky classification were correlated to clinical severity using Spearman analysis. Clinical severity was defined as: severe (required tracheostomy), moderate (obstructive sleep apnea, oral cleft, or gastrostomy-tube), or mild (absence of listed co-morbidities). Cephalometric measurements with a strong correlation (rs>0.60) were identified as predictors of clinical severity. RESULTS: Cephalograms of the study population contained thirty measurements that were found to be significantly different from normative data (p<0.01). These measurements were largely related to maxillary/mandibular projection, maxillary/mandibular plane angle, mandibular morphology, facial height, facial convexity and mandible/throat position. Ten of these 30 statistically significant measurements in addition to Pruzansky classification were found to be strongly correlated (rs>.60) to clinical severity. These measurements include: Mandibular projection/position [Sella-Nasion-Pogonion (SN-Pg) rs=-0.64; Hyoid-Menton (Hy-Me) rs=-0.62]; Posterior facial height [Posterior Facial Height/Anterior Facial Height (PFH/AFH) rs=0.60; Condyle-Gonion (Co-Go) rs=-0.66]; Maxillary/mandibular plane angle [Sella-Nasion-Mandibular Plane (SN-MP) rs=0.62; Frankfort Horizontal-Mandibular Plane (FH-MP) rs=0.61; Sella-Nasion-Palatal Plane (SN-PP) rs=0.69; Sella-Nasion-Symphysis (SN-Symph) rs=-0.69; Pruzansky classification rs=0.82. CONCLUSIONS: Specific cephalometric measurements of increased mandibular retrognathia, decreased posterior facial height, more obtuse maxillary/mandibular plane angle and more obtuse symphasis notch angle are strongly correlated to increased clinical severity in patients with Treacher Collins syndrome.
PMID: 28820843
ISSN: 1529-4242
CID: 2670552
"Does the Organization of Plastic Surgery Units into Independent Departments Affect Academic Productivity?"
Loewenstein, Scott N; Duquette, Stephen; Valsangkar, Nakul; Avula, Umakanth; Lad, Neha; Socas, Juan; Flores, Roberto L; Sood, Rajiv; Koniaris, Leonidas G
BACKGROUND: There is an increased push for plastic surgery units in the United States to become independent departments administered autonomously rather than as divisions of a multispecialty surgery department. The purpose of this research was to determine if there are any quantifiable differences in the academic performance of departments versus divisions. METHODS: Using a list of the plastic surgery units affiliated with The American Council of Academic Plastic Surgeons (ACAPS), unit websites were queried for departmental status and to obtain a list of affiliated faculty. Academic productivity was then quantified using the SCOPUS database. National Institute of Health (NIH) funding was determined through the Research Portfolio Online Reporting Tools database. RESULTS: Plastic surgery departments were comparable to divisions in academic productivity, evidenced by a similar number of publications per faculty (38.9 versus 38.7; p=0.94), number of citations per faculty (692 versus 761; p=0.64), H-indices (9.9 versus 9.9; p=0.99), and NIH grants (3.25 versus 2.84; p=0.80), including RO1 grants (1.33 versus 0.84; p=0.53). There was a trend for departments to have a more equitable male to female ratio (2.8 versus 4.1; p=0.06), and departments trained a greater number of integrated plastic surgery residents (9.0 versus 5.28; p=0.03). CONCLUSIONS: This study demonstrates that the academic performance of independent plastic surgery departments is generally similar to divisions, but with nuanced distinctions.
PMID: 28746240
ISSN: 1529-4242
CID: 2654322
Optimizing Safety of Iliac Bone Harvest Using an Acumed Drill: A Simulated Radiographic Study of 100 Patients
Stranix, John T; Cuzzone, Daniel; Ly, Catherine; Topilow, Nicole; Runyan, Christopher M; Ream, Justin; Flores, Roberto L
OBJECTIVE: To determine the potential risk of visceral injury during Acumed drill iliac crest cancellous bone graft harvest. DESIGN: Radiographic iliac crest anatomic analysis with simulated drill course to measure cancellous bone available for harvest and proximity of vulnerable pelvic structures. SETTING: Single institution, tertiary care university hospital. PATIENTS AND PARTICIPANTS: One hundred pelvic computed tomography scans performed on children 8 to 12 years old without traumatic or neoplastic pathology. INTERVENTIONS: Radiographic simulation of Acumed drill course within iliac bone. MAIN OUTCOME MEASURES: (1) Potential for pelvic visceral injury. (2) Volume of cancellous bone safely available for harvest. RESULTS: Superior and medial cortical thickness at the reference point remained stable across age groups; however, lateral cortical thickness increased with age (3.13 to 3.74 mm, P < .001). Cancellous bone width increased with age at all depths measured (P < .001). Through radiographic simulation, the drill could reach the bowel in 4% of cases and only through gross deviation (>30 degrees ) from the plane of the ilium. There were no cases of simulated bowel perforation within 3 cm of the reference point. The maximum cancellous volume safely harvested increased with age: 24 cc in 8-year-olds to 36 cc in 12-year-olds (P < .001). CONCLUSIONS: Acumed assisted iliac crest bone graft harvest is a safe technique in which substantial amount of cancellous bone can be obtained. The low risk of bowel perforation can be further minimized by limiting the depth of drill bit penetration to less than 3 cm.
PMID: 27632764
ISSN: 1545-1569
CID: 2779922