Customized three-dimensionally printed mandibular external fixator.

The advent of customized three-dimensional (3D) printing allows the affordable manufacturing of sophisticated medical devices, thereby providing swift and simple solutions to specific needs in modern healthcare. Meanwhile, certain devices such as industrial mandibular external fixators (EFs) have become less and less available from medical device companies because of decreased indications. What is more, their handling is often complex. The authors report, step by step, the original design and uneventful clinical use of a 3D-printed, customized mandibular EF. This device was designed together with a positioning and drilling guide for the fixation of a septic mandibular pseudarthrosis. It provided an adequate and satisfactory balance between lightness and rigidity. A simple, accurate and safe placement of the EF was achieved thanks to the skin-supported positioner and drilling guide, thereby making the procedure minimally invasive and time-efficient. To our knowledge, this is the first reported clinical use of a 3D-printed, customized mandibular EF to date. Because such 3D technology is becoming increasingly available to a large number of surgeons, the authors believe that the present innovation could become an alternative to reusable standard EFs.

Gnathodiaphyseal dysplasia with a novel R597I mutation of ANO5: Mandibular reconstruction strategies.

Gnathodiaphyseal Dysplasia (GDD) is a rare, often misdiagnosed, autosomal-dominant disorder due to point mutations in the ANO5 gene. GDD combines craniofacial fibro-osseous lesions, dental loss and progressive curvature and cortical thickening of long bones and vertebra, causing pathological fractures. Diagnosis is based on bone pathology and mutation screening. Here we report three GDD cases within a single family with a novel ANO5 mutation: c.1790 G > T (p.Arg597Ile, i.e. R597I) on exon 16. Microsurgical mandibular reconstructions were performed in the three cases. We reviewed the literature on jaw reconstruction in this condition and discussed the challenges of craniofacial reconstruction in GDD due to the diffuse bone anomalies affecting potential flap donor zones and a specific risk for jawbone osteomyelitis.

Anterior pedicle temporalis muscle flap interposition in the treatment of TMJ disorders.

Temporomandibular joint (TMJ) disorders are a common reason for consultation. Failure of medical treatments sometimes leads to the need for one of many surgical alternatives. Our purpose was to evaluate the results of anterior pedicle temporalis muscle flap interposition in the treatment of TMJ disorders. MATERIAL AND METHODS: For this prospective study, we selected 18 patients who underwent TMJ surgery involving the interposition of a temporalis muscle flap according to a standardized technique, between January 1, 2009 and August 31, 2014. CT imaging was performed on all patients prior to surgery. We documented the etiology of TMJ dysfunction, pre and postoperative pain using a visual analogue scale (VAS), pre and postoperative (last consultation) mouth opening, and complications. We used the Wilcoxon test for our statistical analysis. RESULTS: We observed a significant variation in preoperative and postoperative pain and mouth opening, with an average decrease in VAS values of 4.9/10 and an average increase of mouth opening of 11.1mm. No major complications were observed. DISCUSSION: The interposition of an anterior pedicle temporalis muscle flap in the treatment of temporomandibular joint disorder is a simple and effective technique.

[Study of the normality of the orbito-naso-frontal bandeau]. / Étude de la normalité du bandeau orbito-naso-frontal.

INTRODUCTION: Craniosynostoses are cranio-facial malformations affecting about 1/2100 newborns in France. The involvement of anterior sutures (coronal and metopic) leads to orbito-frontal deformities. The treatment calls upon surgery the goal being, on an esthetic point of view, to restore a normal anatomy. The purpose of our work was to establish if some facial and/or frontal measures easy to perform on a CT are correlated to the global shape of the normal orbito-naso-frontal bandeau (ONFB). MATERIAL AND METHOD: Cranial CTs of 123 consecutive non-malformed children aged between 4 and 12 months were selected in the database of Department of Radiology of the University Hospital of Besançon - France. The CTs were all relocated by rigid transformation in an orthonormal coordinate system. On each of the 123 CTs, 21 reproducible measures representative of the global shape of the ONFB were made. Statistical analyses of these measures were achieved, considering age and gender, in order to determine the correlation between each measure and the ONFB shape. RESULTS: The only measure statistically correlated to the ONFB shape was the distance between the fronto-zygomatic sutures (FZD). The FZD was independent from age (in an interval of 4 months) and from gender. The 20 other measures did not show any correlation with age or gender. DISCUSSION: The FZD allows in itself to determine the ONFB global shape. This measure, easily available on a CT, can help the surgeon to perform a customized reshaping of the ONFB. The development of a surgical template using this measure is ongoing.

[3D printing in health care facilities: What legislation in France?]. / L'impression 3D à l'hôpital: quelle réglementation en France ?

Health care facilities more and more use 3D printing, including making their own medical devices (MDs). However, production and marketing of MDs are regulated. The goal of our work was to clarify what is the current French regulation that should be applied concerning the production of custom-made MDs produced by 3D printing in a health care facility. MDs consist of all devices used for diagnosis, prevention, or treatment of diseases in patients. Prototypes and anatomic models are not considered as MDs and no specific laws apply to them. Cutting guides, splints, osteosynthesis plates or prosthesis are MDs. In order to become a MD manufacturer in France, a health care facility has to follow the requirements of the 93/42/CEE directive. In addition, custom-made 3D-printed MDs must follow the annex VIII of the directive. This needs the writing of a declaration of conformity and the respect of the essential requirements (proving that a MD is secure and conform to what is expected), the procedure has to be qualified, a risk analysis and a control of the biocompatibility of the material have to be fulfilled. The documents proving that these rules have been respected have to be available. Becoming a regulatory manufacturer of MD in France is possible for a health care facility but the specifications have to be respected.

[3D mandibular distraction planification in a case of severe temporomandibular ankylosis]. / Planification 3D d'une distraction mandibulaire dans le cadre d'une ankylose temporo-mandibulaire sévère.

INTRODUCTION: When occurring in childhood, temporomandibular ankylosis joint is responsible for complex maxillofacial deformities, including mandibular growth deficiency. We present a case of temporomandibular joint ankylosis associated with severe mandibular asymmetry treated by mandibular bone distraction performed under computer assistance. OBSERVATION: A 27-year-old patient presented with a severe facial asymmetry consisting in hypoplasia of the left hemi-mandible and maxilla. Mouth opening was non-existent. The CT-scan showed a left temporomandibular ankylosis. A left mandibular distraction was decided. The distraction characteristics (choice and positioning of the distractor, axis and amount of distraction) were determined preoperatively on the 3D CT-scan. The planning has been transferred to a navigation console (Kolibri®, Brainlab®). A combined intraoral and cutaneous was performed. Navigation allowed for an appropriate placement of the osteotomy line and fixation of the distractor. Distraction was started at the 5th postoperative day at the rate of 1mm per day and lasted 25 days without complication. DISCUSSION: 3D planning allows for better indication setting, better preparation of the procedure, reducing complications and operative time. It may help as an educational tool for young surgeons and for a better understanding from the patient. Navigation is an accurate method for the transfer of the planning in the operation room.

[Abdominal perforator flap (DIEP) and autologous latissimus dorsi in breast reconstruction. A retrospective comparative study about the first 60 cases of a same surgeon]. / Le lambeau perforant abdominal (DIEP) et grand dorsal autologue en reconstruction mammaire. Étude rétrospective comparative à propos des 60 premières patientes d'un même opérateur.

INTRODUCTION: Autologous techniques for breast reconstruction get the best cosmetic results. Aesthetic satisfaction with breast reconstruction is an important evaluation criterion. The indication is based on technical criteria (morphological, medical history) and the wishes of the patient. A rigorous evaluation of the results is necessary to assist the patients in their choice of reconstruction. METHODS: Thirty-three DIEP and 27 latissimus dorsi were involved. A satisfaction questionnaire was sent to patients to collect the aesthetic evaluation of their reconstructed breast, sequelae at the donor site of the flap as well as their overall satisfaction. Post-operative photographs of the patients were subject to aesthetical evaluation by two groups of observers. Complications were analyzed. RESULTS: The DIEP tends to get higher aesthetic satisfaction regarding the symmetry of the breasts and the volume of the reconstructed breast (P=0.05), and a better overall satisfaction (P=0.02). The uniformity of the colour of the reconstructed breast was considered superior by observers in the latissimus dorsi group (P=0.005). Donor site scar of DIEP was considered more unsightly while the latissimus dorsi was considered more painful (P=0.04) and uncomfortable, with more frequently contour abnormalities (P=0.03). We noted two total flap necrosis and three partial necrosis in the group DIEP, and two partial flap necrosis in the group latissimus dorsi. CONCLUSION: This study provides evidence that can guide the patient and the surgeon in the complex process of therapeutic decision, without exempting the latter from a careful selection of indications.

[Computer-assisted navigation in orthognathic surgery. Application to Le Fort I osteotomy]. / La navigation en chirurgie orthognathique. Application à l'ostéotomie de Le Fort I.

Computer-assisted navigation is a tool that allows the surgeon to reach intraoperatively a previously defined target. This technique can be applied to the positioning of bone fragments in orthognathic surgery. It is not used routinely yet because there are no specifically dedicated systems available on the market for this kind of surgery. The goal of our study was to describe the various systems that could be used in orthognathic surgery and to report our experience of computer-assisted surgery in the positioning of the maxilla during maxillomandibular osteotomies.