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Purpose Following the introduction of the Regulation (EU) 2017/745 by the European Parliament, any bioactive substance or surgical implant introduced into the human body must be documented. The regulation requires any implant to be traced back to the manufacturer. Lot numbers need to be available for every single medical implant. Also, the manufacturer is required by law to provide implants individually packaged and sterilized. Previously, model tray systems (MOS tray) were used for osteosynthesis in oral and maxillofacial surgery, in which the individual implants could not be registered separately. The new regulation made it impossible to use such processes during surgery anymore and a need for a change in the medical practice surged. We examined a possible solution for the new legislation. The aim of this prospective cohort study is to analyze the MOS tray systems to osteosynthesis materials prepackaged in sets. We record and evaluate parameters such as surgical time and documentation time. We perform a short cost analysis of our clinic. The primary aim is to determine how much time is gained or lost by the mandatory increased patient safety. The secondary aim is to describe change in costs. Methods Patients that underwent standard surgical procedures in the clinic of oral and maxillofacial surgery of the faculty hospital Carl Gustav Carus in Dresden were included. We chose open reduction and internal fixation (ORIF) of anterior mandibular corpus fractures as well as mandibular advancement by means of bilateral sagittal split osteotomies (BSSO) as standardized procedures. Both of these procedures require two osteosynthesis plates and at least four screws for each plate. MOS trays were compared to prepackaged sterilized sets. The sets include a drill bit, two plates, and eight 5-mm screws. A total number of 40 patients were examined. We allocated 20 patients to the ORIF group and the other 20 patients to the BSSO group. Each group was evenly subdivided into a MOS tray group and a prepackaged group. Parameters such as the incision-suture time (IST) as well as the documentation time (DT) by the operating room (OR) staff to complete documentation for the implants are the main focus of investigation. Results For open reduction, the incision-suture time was significantly different in favor of the MOS tray (p p Conclusions By law, a change in the method of approaching surgery is necessary. For standardized procedures, the right choice of implants can lead to a reduction of documentation time and costs for implant material, sterilization, as well as utilizing less instruments. This in turn leads to lower costs for perioperative processing as well as provision of state-of-the-art implant quality implementing higher patient security.

Purpose The use of titanium-based implants in mandibular condyle fractures can require implant removal because of screw penetration through the condylar surface. The use of biodegradable implants can avoid a second operation for implant removal and the associated possible complications. We investigated the clinical and radiologic outcomes of osteosynthesis of mandibular condyle fractures (MCFs) with biodegradable magnesium-based compression screws. Materials and Methods We performed a retrospective observational study of 6 patients who had been treated at our department. We recorded the changes in jaw movements over time, occlusion, and possible complications at defined intervals of 1, 3, 6, and 12 months postoperatively. We also compared the preoperative computed tomography (CT) scans with the postoperative cone-beam CT (CBCT) scans at 6 and 12 months postoperatively to evaluate mandibular condyle healing and screw degradation. Results Of the 6 patients, 4 were men and 2 were women, with a mean age of 43.2 years (range, 30 to 66 years). All 6 patients had unilateral MCFs. All the patients showed well-restored function of the temporomandibular joint with significant improvement in mouth opening (46.17 ± 6.49 mm), right (10.67 ± 1.03 mm) and left (10.67 ± 1.97 mm) laterotrusion, and protrusion (10.17 ± 1.33 mm) distances to physiologic values. The CBCT scans showed the remodeling processes of the mandibular condyle and a few radiolucencies indicating the magnesium-based screws. Although penetration of 1 screw tip through the condylar surface had occurred, no implant removal was necessary owing to biodegradation of the implant. Conclusions The results of the present study have shown that biodegradable magnesium-based compression screws provide good clinical results and avoid implant removal.

The intraoral approach is favoured by many patients and surgeons for the treatment of fractures of the condylar neck, but the limited space offered by this approach can make positioning and fixation of the osteosynthesis plate difficult. A rhombic-shaped plate was designed specifically for use with the intraoral approach, and introduced into our clinical practice in 2012. We present the clinical and functional results in 81 patients with 98 fractures of the condylar neck who we have treated with this technique. Of these six required surgical revision, and ultimately all but two had satisfactory occlusion and mandibular function. Our complication rate of 6/81 (7.4%) compares favourably with those reported elsewhere, and confirms that open reduction and internal fixation of condylar fractures using the Rhombic plate through an intra-oral approach provides good outcomes.

It is difficult to fix fractures of the condylar head of the mandible. Several techniques have been described which show satisfactory outcomes, but stability can be questionable, and some can cause irritation of the soft tissues. We describe a technique and first results of treating such fractures with resorbable magnesium-based headless bone screws (Magnezix® 2.7mm CS; Syntellix AG, Hanover, Germany).

Purpose The aim of the present study was to evaluate the biomechanical stability of osteosynthesis in mandibular condyle fractures using a newly designed rhombic 3-dimensional (3D) condylar fracture plate and compare it with that using standard two 4-hole miniplates and with that in nonfractured condyles. Materials and Methods Using 200 porcine mandibles, 3 different monocortical plating techniques were evaluated. The condyles were fractured along a defined line tangentially through the sigmoid notch and perpendicular to the posterior border. After anatomic reduction, osteosynthesis was performed using either standard rhombic 3D condylar fracture plates and standard screws (group A) or locking rhombic 3D condylar fracture plates, which were fixed either with standard screws (group B) or locking screws (group C). For comparison, nonfractured condyles (group D) and condyles fixed with standard two 4-hole miniplates and 8 screws (group E) were included. Using a universal mechanical testing machine (TIRA Test 2720; TIRA GmbH Schalkau, Germany), each group was subjected to linear loading from laterally to medially, medially to laterally, anteriorly to posteriorly, and posteriorly to anteriorly. The maximum axial force and displacement at the maximum force were measured. The mean values were compared for statistical significance using analysis of variance with Bonferroni's correction (statistical significance set at P Results The main mode of failure in the plating techniques investigated was the pull out of screws from the proximal fragment. We found no statistically significant differences in the stability of osteosynthesis between the two 4-hole miniplates and the rhombic 3D condylar fracture plate when loading from posteriorly to anteriorly, laterally to medially, and medially to laterally. However, when loading from anteriorly to posteriorly, a statistically significant difference between the standard and locking system and the two 4-hole miniplate system was observed, with the latter proving more stable. Conclusions The results of the present biomechanical study suggest that the rhombic 3D condylar fracture plates are suitable for the treatment of condylar neck fractures. Both types of the plate are able to resist physiologic strains comparable to the two 4-hole miniplates.

Purpose The aim of this study was to evaluate in mandibular condylar process fractures the biomechanical stability of osteosynthesis using the Delta plate and the TriLock Delta condyle trauma plate and to compare these with 2 4-hole miniplates. Materials and Methods The condyles of 120 porcine mandibles were fractured at a defined location. After anatomic reduction, the fractures were fixed with a Delta plate, a TriLock Delta condyle trauma plate, or 2 4-hole miniplates (40 per group). Each group was subjected to linear loadings in 4 different directions with a universal mechanical testing machine (TIRA Test 2720). Yield load and yield displacement were measured for the 2 Delta plates and the 2 miniplates. Means were derived and compared for statistical significance using the Kruskal-Wallis test with a confidence level of 95% ( P Results None of the plates broke. In 4 cases using the double miniplate and in 2 cases using the Delta plate, osteosynthesis screw loosening was registered. In lateral-to-medial and anterior-to-posterior directions, the 2 miniplates tolerated the highest loads. From medial to lateral and from posterior to anterior, the TriLock Delta condyle trauma plate resisted the highest loads. However, there was a statistically significant difference among all osteosynthesis systems only for medial-to-lateral loads. Statistical analysis for displacement showed significant differences among all plates in the 4 directions. Conclusions This biomechanical study indicates that for rigid internal fixation of condylar fractures of the mandible, similar to 2 miniplates, the 2 Delta plates (Delta plate with gliding holes and TriLock Delta plate) fulfill the principles of a functional and stable osteosynthesis. Both are able to resist physiologic strains. The locking plate (TriLock Delta condyle trauma plate) has the advantages of greater primary stability and decreased likelihood of screw loosening.

Background. Primary reconstruction of the man- dible is the golden standard of surgical treatment after abla- tive tumor surgery. Many different microvascular bone grafts are used to reduce wound healing complications at the severely compromised recipient site. The loss of primary grafts due to radiotherapy or osteoradionecrosis can make secondary mandibular reconstruction necessary. To address this problem, we developed the technique of the prefabrica- tion of a radial forearm flap with cancellous bone. The aims were to establish these techniques into the clinical routine and to create a safe and reliable flap with low donor site morbidity. Methods. In patients who had undergone ablative tumor surgery radiochemotherapy, and primary reconstruction, pre- fabricated bony radial forearm flaps (PBRFFs) were applied for secondary reconstruction of the mandible. Cylinders of cancel- lous bone taken from the iliac crest were implanted in the lower forearm to allow the necessary vascularization. After a healing period of 4 weeks, the PBRFF was elevated and grafted into the mandibular defect. Results. All grafts healed uneventfully. However, 1 case required revision of the venous anastomosis after 2 days. The transplants improved the contour of the lower face enabling a good correction of the facial asymmetry. During the follow-up of up to 4 years, the radiographic controls showed good bony consolidation between the graft and the stumps of the mandi- ble as well as formation of cortical bone around the cancellous bone cylinders. Conclusion. These results demonstrate that the PBRFF is a safe and reliable graft which provides alternate solution in which other microvascular bone grafts have already failed. In the future, the iliac bone graft may be replaced with scaffold seeded with stem cells for further reduction of donor site mor- bidity. V C 2009 Wiley Periodicals, Inc. Head Neck 31: 1579- 1587, 2009

We describe a new design of resorbable plate for use in the treatment of fractures of the condylar neck, and report the outcome of initial treatment in two patients.

We prospectively studied two groups of 30 patients to assess the outcome of treatment of mandibular fractures with the biodegradable INION ® system compared with osteosynthesis with titanium miniplates. The degree of occlusion, wound healing, and swelling, were noted preoperatively and at 1 week, 6 weeks, and 6 months postoperatively. All fractures healed uneventfully, both clinically and radiologically, and independently of the osteosynthesis used. We found no long-term disturbance of occlusion, but there were twice as many malocclusions in the INION ® group at one week. We now use a 3–5 day period of postoperative elastic intermaxillary fixation (IMF) to prevent material deformities. Both groups developed problems with wound healing; with INION ® adequate soft tissue closure combined with appropriate positioning of the plates prevented this. At 6 months a dense swelling developed in some patients in the INION ® group as a result of biodegradation of the plates. INION ® plates were biocompatible and strong enough to treat mandibular fractures.