Hybrid workflow for custom-made medical devices: A case report about nasal reconstruction.

Specialist industries usually develop custom-made medical devices outside a medical structure at the request of a healthcare professional. Access to 3D-printing technology with dedicated softwares in hospitals allow surgeons to perform virtual surgery leading to safer and more precise surgery. The authors present the hybrid workflow that combined the skills of surgeons, engineers and manufacturers to create titanium custom-made cutting guide and implants to reconstruct the nasal bone after the resection of an intraosseous hemangioma. This process aimed to optimize pre-operative planning, to improve precision, to predict the esthetic results of reconstruction. Moreover, it leads to a reduction of manufacturing time and the overall costs of surgery and to achieve genuine custom-made care.

Rhinogoniometer: Validation of an Instrument for Rhinoplasty.

SUMMARY: The position of the lower lateral cartilages is directly related to good nasal functionality. When these cartilages exhibit cephalic malposition, the angle of divergence between cartilages is usually less than 60 degrees, which can cause external nasal valve insufficiency. The objective of this study was to validate the rhinogoniometer, an innovative surgical instrument that allows for diagnosing the position of this cartilage intraoperatively. In the intraoperative period, the angle of divergence, which is the angle formed between the two lateral branches of the lower lateral cartilages, was measured in 31 primary rhinoplasty patients. The rhinogoniometer measurement was compared with that of the computerized analysis, and the reproducibility of measurements with the rhinogoniometer between two different surgeons was determined. When comparing the values obtained by the two methods, a significant difference was found (p = 0.034). On average, the angles measured by the rhinogoniometer were 3.7 degrees smaller than the measurements made by the software. It was observed that when the angles measured by both methods were above 75 degrees, the differences between the two measurements were higher (p = 0.022). However, for angles up to 75 degrees, the measurement using the rhinogoniometer was, on average, 0.79 degrees higher than the measurement taken by the software. When the difference in angles obtained by the two methods between different surgeons was evaluated, there was a significant difference (p < 0.023). In conclusion, at angles up to 75 degrees, the rhinogoniometer showed a negligible difference of 0.79 degrees higher than the measurement obtained via software. Measurements with the rhinogoniometer were also shown to be reproducible with different surgeons.

Flexible Tongue-in-Groove Technique and Its Effectiveness Compared to Classic Tongue-in-Groove and Columellar Strut Graft Techniques: A Retrospective Analysis of 237 Open Rhinoplasty Cases.

BACKGROUND: The medial crura are almost always supported in tip surgery using columellar strut graft placement or tongue-in-groove suturing to the caudal septum. In this study, the authors present a modified tongue-in-groove (called "flexible tongue-in-groove") technique. METHODS: A total of 237 patients who underwent open rhinoplasty between January of 2016 and June of 2018 were included in this retrospective study. The patients were divided into three main groups: (1) flexible tongue-in-groove, (2) classic tongue-in-groove, and (3) columellar strut. Using standardized preoperative and postoperative (1-, 6-, and 12-month) lateral view photographs, the nasolabial angle and Goode ratio were measured for nasal tip rotation and projection, respectively. RESULTS: Flexible tongue-in-groove (n = 53) and classic tongue-in-groove (n = 107) techniques showed a significantly smaller decrease in the nasolabial angle from month 1 to month 12 than did the columellar strut technique (n = 77) (p < 0.05). These statistically significant differences were not found when the time intervals were narrowed (p > 0.05). Flexible and classic tongue-in-groove techniques showed significantly higher Goode ratios than did the columellar strut technique at 1, 6, and 12 months (p < 0.05 for all). In various analyses using the nasolabial angle and Goode ratio, no statistically significant difference was found between flexible and classic tongue-in-groove techniques (p > 0.05). CONCLUSIONS: Flexible and classic tongue-in-groove techniques provide more durable results in nasolabial angle and Goode ratio measurements than does the columellar strut technique in primary open-approach rhinoplasty. The flexible tongue-in-groove technique is as robust as the classic tongue-in-groove technique in appropriate cases. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

A comparison of piezo surgery osteotomies with conventional internal osteotomies as performed by trainee surgeons: a cadaveric study.

INTRODUCTION: Aesthetic rhinoplasty remains a challenging procedure with high expectations and narrow tolerance for errors. Considerable training is required to achieve controlled and reliable results. Use of the Piezotome is gaining popularity for performing the nasal osteotomies, a key step in rhinoplasty, where it is reported to improve precision and predictability and to keep tissue damage to a minimum. We compare the outcomes of conventional osteotomy techniques to piezosurgery in human cadavers as undertaken by surgical trainees. MATERIALS AND METHODS: Seven human cadavers were used and a total of 14 osteotomies were performed. Conventional osteotomies and piezosurgery were carried out each on one side of the cadaver. A number of fragments and a blinded assessment of the accuracy of the osteotomy compared with the preprocedure skin markings were carried out by two experienced rhinoplasty surgeons. The Mann-Whitney test for statistical analysis was used. RESULTS: The mean number of fragments was 1.57 in the piezosurgery osteotomy and 2.14 using conventional osteotomies. Four of seven piezosurgery osteotomies achieved an accuracy within 1mm. The conventional osteotomies as performed by the trainees showed a significant mismatch of more than 3mm in three of seven of cases. Accuracy within 1mm was achieved in one of seven cases. DISCUSSION: Piezosurgery offers a safe, reliable and precise method of performing lateral nasal osteotomies. This human cadaver study shows a high accuracy of osteotomy and fewer comminuted fractures using this technique compared with conventional osteotomy techniques.

Laser-Assisted Rhinoplasty: The Future Generation Rhinoplasty Technique to Preserve Anatomy? A Series of Patients Compared to Patients Undergoing Standard Open Rhinoplasty.

BACKGROUND: Rhinoplasty is the cosmetic procedure that is most difficult to master. Anatomical preservation should represent the main goal of rhinoplasty. One emerging tool appears to be erbium:yttrium-aluminum-garnet laser bone and cartilage reshaping. The authors developed a new small laser hand probe to perform what we called laser-assisted rhinoplasty. The authors evaluate the feasibility of the laser-assisted rhinoplasty and the aesthetic and functional result of laser-assisted rhinoplasty compared to classic rhinoplasty. METHODS: A total of 50 patients were enrolled and randomized into two cohorts: the first cohort of patients was submitted to classic rhinoplasty, and the second cohort to laser-assisted rhinoplasty. The laser beam was used to perform both the resection of the crura and the resection of the nasal hump and osteotomies. RESULTS: Laser-assisted rhinoplasty is a safe and reproducible technique. At a clinical assessment, lateral crura reshaping showed a visible step or excessive skin retraction in 12 percent of the classic rhinoplasty population with thick cartilage and/or thin skin, and this was not present in the laser-assisted rhinoplasty population at 12-month follow-up. The patient satisfaction rate was higher in the laser-assisted rhinoplasty population compared with standard open rhinoplasty. The authors also clinically noted a reduction in edema in the immediate postoperative period in the laser-assisted rhinoplasty population and a more rapid complete resolution of the swelling. CONCLUSION: The laser-assisted rhinoplasty technique is feasible and safe and has no major complication, and the aesthetic and functional results can be superimposed onto classic rhinoplasty but with a higher degree of intraoperative precision, higher patient satisfaction, a cleaner field, and less bleeding.

A Comparative Analysis Between Primary and Secondary Nasal Tip Drooping.

OBJECTIVE: Recently, many commercial one-piece alloplastic materials are used in nasal dorsum augmentation and increased nasal tip projection, but there is no study about their effects with regard to size on nasal shape so far. The aim of this study is to evaluate the impact of oversized one-piece alloplastic implant on nasal tip projection. METHODS: We categorized nasal tip drooping as primary (group 1: no rhinoplasty or trauma history) and secondary (group 2: previous history of augmentation rhinoplasty with one-piece alloplastic materials), and retrospectively compared the characteristics of primary and secondary nasal tip drooping on the basis of pre- and postoperative rhinological parameters (nasolabial angle [NLA], rotation angle, nasofrontal angle [NFA], and Goode ratio). RESULTS: A total of 50 patients were enrolled and completely reviewed. The mean age was 27.46 years (ranging from 19 to 49 years) in group 1 and 31.33 years (ranging from 20 to 47 years) in group 2. The postoperative NLA and rotation angle were not statistically different between 2 groups, but the postoperative NFA and postoperative Goode ratio were statistically different between 2 groups by independent t test. When we further performed univariate and multivariate analysis, the postoperative Goode ratio was the only factor that was significantly different between the 2 groups. CONCLUSION: Insertion of one-piece alloplastic implants from nasal tip glabella to dome of nasal tip may induce secondary nasal tip drooping. The degree of recovery of nasal tip projection is different between 2 groups and may be obtained by a more delicate surgical techniques.

Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty.

Importance: A validated biomaterial would have several medical advantages in septorhinoplasties requiring a large-volume graft such as avoiding donor site morbidity, making ambulatory surgery possible, and reducing surgical costs. Objective: To assess the safety and efficacy of a ceramic to treat saddle and crooked noses. The main endpoint was the biocompatibility of the implant. The secondary endpoint was its functional and aesthetic efficacy. Design, Setting, and Participants: The nasal septum (NASEPT) study is a pilot multicenter noncomparative prospective phase IIa clinical trial. The biomaterial tested was a biphasic calcium phosphate implant composed of 75% hydroxyapatite and 25% beta tri calcium phosphate. This versatile material can be used to replace septal skeleton when it is absent or nonusable. We included 25 patients with a multifractured osseous and cartilaginous framework after several traumas or surgeries. The implant placement technique was identical to an extracorporeal septoplasty through the external approach. Main Outcomes and Measures: The primary endpoint was the occurrence of expected adverse and severe adverse events. The secondary endpoints were clinical functional and aesthetic results and histological microscopic modifications. Results: Any extrusion, infection, pain, and epistaxis were observed. All implants were placed in a sagittal, straight, and solid position without extralobular depression. Comparisons between pre- and postoperative symptoms showed that nasal comfort (p < 10-4) and quality of life (p < 10-4) were dramatically improved in all patients. The nasolabial angle (p = 0.047) and the columellar projection (p = 0.024) were improved after surgery. Histological data showed little submucosal inflammation at 6 months with well-differentiated epithelium. The mean follow-up was 23 months: three patients underwent revision surgery for functional or aesthetic details and four implants were removed (16%) owing to a foreign body reaction between 17 and 74 months. Conclusion and Relevance: The NASEPT implant meets functional and aesthetic requirements in complex septorhinoplasties but its long-term biocompatibility needs to be improved. It could potentially avoid donor site morbidity.

A Prospective Randomized Trial of N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone for Grafting in Rhinoplasty: 9 year Follow-up.

OBJECTIVE: Use of cyanoacrylate glue in facial plastic surgery is still controversial due to the absence of long-term follow up showing the results. Aim of our study is comparing the long-term outcomes of N-butyl-cyanoacrylate + Metacryloxysulfolane versus traditional sutures in rhinoplasty. METHODS: Prospective comparative study. One hundred forty-two patients affected by ptotic nasal tip were included and randomized in two groups. In group A, the surgeon fixed the graft by using the glue and suture and in group B by using the traditional suture only. The following data were collected and compared by statistical analysis: nasolabial angle before and after surgery, dimensions of the graft, duration time (in minutes) for graft application during the surgery, number of sutures applied to fix the graft, presence of post-surgery negative outcomes. RESULTS: All patients statistically improved their nasolabial angle after surgery (ANOVA: P < .0001) without statistically significant differences between the two groups both at short and long follow-up (χ:P = 1 and P = .9 respectively). A statistically significant difference in graft fixation time (P < .00001) and number of sutures (t: P < .00001) used was observed between the two groups. No statistically significant difference was observed in prevalence of infection after surgery. CONCLUSION: N-butyl-cyanoacrylate + Metacryloxysulfolane could be a valid tool to reduce the necessary number of sutures and to reduce the time required for graft fixation graft fixation with consistent results in long-term follow-up.

Utilization fraction of rhinoplasty instrument sets: Model for efficient use of surgical instruments.

OBJECTIVES: Recognize the avoidable costs incurred due to overpacking of rhinoplasty instrument trays. Reduce rhinoplasty instrument trays by including only instruments used frequently. Establish methods to reduce trays prepared for other otolaryngologic procedures. METHODS: This is a prospective study. The study evaluates the specific use of instruments opened for rhinoplasty procedures at the New York Eye & Ear Infirmary of Mount Sinai. Instruments were counted in 10 rhinoplasty cases. Usage rate was calculated for each instrument. Additionally, all instruments used in at least 20% of cases were noted. This "20%" threshold was used to create new rhinoplasty tray inventories more reflective of actual instrument usage. Some instruments above the 20% threshold were included in multiples (i.e. two Adson Brown forceps vs. one curved iris scissor). RESULTS: 189 instruments were opened, and 32 instruments were used on average in each rhinoplasty. 55 instruments were used in at least 20% of cases. The 55 "high usage" instruments were used to create new, reduced rhinoplasty tray inventory lists. Based on our analysis, a new rhinoplasty tray inventory was created comprised of 68 instruments, a 64% reduction from 189. CONCLUSION: Instruments are sterilized and packed in gross excess for rhinoplasty procedures. Previously published figures estimate re-sterilization costs of $0.51 to $0.77 per instrument. Reduction in instruments opened from 189 to 68 is expected to lead to cost savings ranging from $62 to $93 per case, yielding a savings between $6200 and $9300 per 100 cases performed. LEVEL OF EVIDENCE: II-3.

Powered Rhinoplasty: A Simple Step-by-Step Approach.

SUMMARY: Reduction of a nasal hump and nasal base narrowing are very common steps during a primary rhinoplasty procedure. The greatest difficulty is to obtain stable fracture lines, a natural appearance, beautiful dorsal aesthetic lines, and the absence of palpable or visible irregularities, especially in the long term. The surgeon strives for a reproducible technique, which seems to be more feasible with mechanical osteotomies (powered or piezoelectric) than with traditional manual osteotomies. The aim of this article is to describe powered osteotomy in a step-by-step fashion to provide a clear guideline for rhinoplasty surgeons.

Key Points in Subperichondrial-Subperiosteal Dissection.

"Subperichondrial-subperiosteal dissection technique (SSDT) decreases soft tissue injury to a minimum by protecting soft tissues from dissection and retraction traumas. The fact remains that dissecting the perichondrium of the nasal tip cartilages is not effortless. Cartilages may be harmed if dissection is not initiated at the right location. The aforementioned surgeons have routinely used the SSDT between the years 2008 and 2019 in more than 4000 rhinoplasties. The number of the surgeons making use of the SSDT will increase with the understanding of the key points in dissection, their ordering, and use of correct instrumentation."

Preservation Rhinoplasty: The Endonasal Cottle Push-Down/Let-Down Approach.

Preservation rhinoplasty is a new term for an old technique. The authors have used the endonasal push-down and let-down techniques that are attributed to Dr Maurice Cottle throughout their careers on select patients with excellent success. The endonasal Cottle technique allows the authors to manage the nasal dorsum in a conservative fashion, reducing the need for routine restructuring of the middle third and nasal dorsum. The details of their approach are presented in this publication.

Piezoelectric Osteotomies in Dorsal Preservation Rhinoplasty.

Dorsal preservation rhinoplasty requires precise management of the osseocartilaginous vault. Ultrasonic piezo instruments offer several advantages compared with traditional tools such as hand saws, rasps, and osteotomes. As always, an understanding of the dynamics of manipulation of the vault, anatomy, and proper technique are paramount and are reviewed herein.

Use of Nasal Implants and Dorsal Modification When Treating the East Asian Nose.

Dorsal augmentation and tip surgery are essential procedures for East Asians seeking rhinoplasty, because they generally have thicker skin and poorly developed nasal dorsum and tip. For dorsal augmentation, many Asian surgeons prefer using alloplastic material, like silicone, Gore-Tex, and filler injection, for cost-effectiveness, easy handling, and short operation times. Compared with autologous implant materials, the use of synthetic implant is suggested to be associated with many complications, such as infection, extrusion, and deviation. However, even with the use of the autologous material, problems such as reabsorption after grafting, donor site complications can take place.