Evidence Based Development of a Novel Lateral Fibula Plate (VariAx Fibula) Using a Real CT Bone Data Based Optimization Process During Device Development

Development of novel implants in orthopaedic trauma surgery is based on limited datasets of cadaver trials or artificial bone models. A method has been developed whereby implants can be constructed in an evidence based method founded on a large anatomic database consisting of more than 2.000 datasets of bones extracted from CT scans. The aim of this study was the development and clinical application of an anatomically pre-contoured plate for the treatment of distal fibular fractures based on the anatomical database. 48 Caucasian and Asian bone models (left and right) from the database were used for the preliminary optimization process and validation of the fibula plate. The implant was constructed to fit bilaterally in a lateral position of the fibula. Then a biomechanical comparison of the designed implant to the current gold standard in the treatment of distal fibular fractures (locking 1/3 tubular plate) was conducted. Finally, a clinical surveillance study to evaluate the grade of implant fit achieved was performed. The results showed that with a virtual anatomic database it was possible to design a fibula plate with an optimized fit for a large proportion of the population. Biomechanical testing showed the novel fibula plate to be superior to 1/3 tubular plates in 4-point bending tests. The clinical application showed a very high degree of primary implant fit. Only in a small minority of cases further intra-operative implant bending was necessary. Therefore, the goal to develop an implant for the treatment of distal fibular fractures based on the evidence of a large anatomical database could be attained. Biomechanical testing showed good results regarding the stability and the clinical application confirmed the high grade of anatomical fit.

Biomechanical evaluation of different angle-stable locking plate systems for mandibular surgery

PURPOSE To compare the initial stability and stability after fatigue of three different locking systems (Synthes(®), Stryker(®) and Medartis(®)) for mandibular fixation and reconstruction. METHOD Standard mandible locking plates with identical profile height (1,5 mm), comparable length and screws with identical diameter (2,0 mm) were used. Plates were fixed with six screws according a preparation protocol. Four point bending tests were then performed using artificial bone material to compare their initial stability and failure limit under realistic loading conditions. Loading of the plates was performed using of a servo hydraulic driven testing machine. The stiffness of the implant/bone construct was calculated using a linear regression on the experimental data included in a range of applied moment between 2 Nm and 6 Nm. RESULTS No statistical difference in the elastic stiffness was visible between the three types of plate. However, differences were observed between the systems concerning the maximal load supported. The Stryker and Synthes systems were able to support a significantly higher moment. CONCLUSION For clinical application all systems show good and reliable results. Practical aspects such as handling, possible angulation of screw fixation, possibility of screw/plate removal, etc. may favour one or the other plating system.

Symptomatic plate removal after treatment of facial fractures

AIMS: To identify the rates and reasons for plate removal (PR) among patients treated for facial fractures. MATERIALS AND METHODS: A retrospective review of files of 238 patients. RESULTS: Forty-eight patients (20.2%) had plates removed. The reason for removal was objective in 33.3% and subjective in 29.2%. The most common subjective reason was cold sensitivity, and the most common objective reason was wound dehiscence/infection. Women had PR for subjective reasons more often than men (p=0.018). Removal was performed more often for subjective reasons after zygomatico-orbital fractures than after mandibular fractures (p=0.002). Plates inserted in the mandible from an intraoral approach were removed more frequently than extraorally inserted mandibular plates, intraorally inserted maxillary plates, and extraorally inserted plates in other locations (p<0.001). Orbital rim plates had a higher risk of being removed than maxillary or frontal bone plates (p=0.02). CONCLUSIONS: Subjective discomfort is a notable reason for PR among Finnish patients, suggesting that the cold climate has an influence on the need for removal. Patients receiving mandibular osteosynthesis with miniplates from an intraoral approach are at risk of hardware removal because of wound dehiscence/infection and loose/broken hardware, reminding us that more rigid fixation devices should not be forgotten despite the widespread use of miniplates.

Coronal plane segmental flexibility in thoracic adolescent idiopathic scoliosis assessed by fulcrum-bending radiographs

Knowledge about segmental flexibility in adolescent idiopathic scoliosis is crucial for a better biomechanical understanding, particularly for the development of fusionless, growth-guiding techniques. Currently, there is lack of data in this field. The objective of this study was, therefore, to compute segmental flexibility indices (standing angle minus corrected angle/standing angle). We compared segmental disc angles in 76 preoperative sets of standing and fulcrum-bending radiographs of thoracic curves (paired, two-tailed t tests, p < 0.05). The mean standing Cobb angle was 59.7 degrees (range 41.3 degrees -95 degrees ) and the flexibility index of the curve was 48.6\% (range 16.6-78.8\%). The disc angles showed symmetric periapical distribution with significant decrease (all p values <0.0001) for every cephalad (+) and caudad (-) level change. The periapical levels +1 and -1 wedged at 8.3 degrees and 8.7 degrees (range 3.5 degrees -14.8 degrees ), respectively. All angles were significantly smaller on the-bending views (p values <0.0001). We noted mean periapical flexibility indices of 46\% (+1), 49\% (-1), 57\% (+2) and 81\% (-2), which were significantly less (p < 0.001) than for the group of remote levels 105\% (+3), 149\% (-3), 231\% (+4) and 300\% (-4). The discal and bony wedging was 60 and 40\%, respectively, and mean values 35 degrees and 24 degrees (p < 0.0001). Their relationship with the Cobb angle showed a moderate correlation (r = 0.56 and 0.45). Functional, radiographic analysis of idiopathic thoracic scoliosis revealed significant, homogenous segmental tethering confined to four periapical levels. Future research will aim at in vivo segmental measurements in three planes under defined load to provide in-depth data for novel therapeutic strategies.

Adult Proximal Humerus Locking Plate for the Treatment of a Pediatric Subtrochanteric Femoral Nonunion: A Case Report

Nonunions of pediatric subtrochanteric femur fractures are exceedingly rare and have to date not been reported in the literature. We present the case of an 11-year-old boy who developed such a nonunion after open reduction internal fixation using a pediatric locked proximal femur plate. Using an adult proximal humerus locking plate, adequate proximal fixation of the nonunion was obtained. Furthermore, previously placed distal screw holes were safely bridged and the biomechanical environment around the nonunion site improved. Uneventful healing was possible with the use of adjuvant bone grafting. No short- or midterm complications occurred. Although other implants can certainly be adapted to a use different than that of its original design, the present case suggests that adult proximal humerus locking plates may be a safe option for revision surgery of the proximal pediatric femur.

Minimization of Intra-Operative Shaping of Orthopaedic Fixation Plates: A Population-Based Design

In this paper we present a new population-based method for the design of bone fixation plates. Standard pre-contoured plates are designed based on the mean shape of a certain population. We propose a computational process to design implants while reducing the amount of required intra-operative shaping, thus reducing the mechanical stresses applied to the plate. A bending and torsion model was used to measure and minimize the necessary intra-operative deformation. The method was applied and validated on a population of 200 femurs that was further augmented with a statistical shape model. The obtained results showed substantial reduction in the bending and torsion needed to shape the new design into any bone in the population when compared to the standard mean-based plates.

Population-Based Design of Mandibular Plates Based on Bone Quality and Morphology

In this paper we present a new population-based implant design methodology, which advances the state-of-the-art approaches by combining shape and bone quality information into the design strategy. The method enhances the mechanical stability of the fixation and reduces the intra-operative in-plane bending which might impede the functionality of the locking mechanism. The method is presented for the case of mandibular locking fixation plates, where the mandibular angle and the bone quality at screw locations are taken into account. Using computational anatomy techniques, the method automatically derives, from a set of computed tomography images, the mandibular angle and the bone thickness and intensity values at the path of every screw. An optimisation strategy is then used to optimise the two parameters of plate angle and screw position. Results for the new design are presented along with a comparison with a commercially available mandibular locking fixation plate. A statistically highly significant improvement was observed. Our experiments allowed us to conclude that an angle of 126° and a screw separation of 8mm is a more suitable design than the standard 120° and 9mm.

Femoral morphology and epiphyseal growth plate changes of the hip during maturation: MR assessments in a 1-year follow-up on a cross-sectional asymptomatic cohort in the age range of 9-17 years

The goal of this prospective study was to characterize the morphology and physeal changes of the femoral head during maturation using MRI in a population-based group of asymptomatic volunteers.

Use of a 1.5 mm butterfly locking plate for stabilization of atlantoaxial pathology in three toy breed dogs

The objective of this study was to describe the use of a titanium 1.5 mm locking plate in the stabilization of atlantoaxial pathology in three toy breed dogs. Two dogs with atlantoaxial subluxation and another dog with an axial fracture, confirmed by diagnostic imaging, were stabilized via a ventral approach with a 1.5 mm titanium 5-hole locking butterfly-plate. Surgical reduction and stabilization were assessed by computed tomography and radiography after surgery. Follow-up evaluation for resolution of neurological signs and possible complications was performed in all three dogs. For long-term assessment, a telephone follow-up was performed. A considerable improvement of neurological signs occurred within two to four weeks after surgery. An excellent clinical outcome was identified in all three patients. Adequate stabilization and resolution of neurological signs in all three dogs was achieved. The stabilization of atlantoaxial surgical conditions in toy breeds with the 1.5 mm titanium 5-hole butterfly locking plate appears to be an effective means of surgical treatment.

The Locking Compression Paediatric Hip Plate: technical guide and critical analysis

Osteotomies of the proximal femur and stable fixation of displaced femoral neck fractures are demanding operations. An LCP Paediatric Hip Plate was developed to make these operations safer and less demanding. The article focuses on the surgical technique and critically analyses the device.

Population-based design of mandibular fixation plates with bone quality and morphology considerations

In this paper we present a new population-based implant design methodology, which advances the state-of-the-art approaches by combining shape and bone quality information into the design strategy. The method may enhance the mechanical stability of the fixation and reduces the intra-operative in-plane bending which might impede the functionality of the locking mechanism. The computational method is presented for the case of mandibular locking fixation plates, where the mandibular angle and the bone quality at screw locations are taken into account. The method automatically derives the mandibular angle and the bone thickness and intensity values at the path of every screw from a set of computed tomography images. An optimization strategy is then used to optimize the two parameters of plate angle and screw position. The method was applied to two populations of different genders. Results for the new design are presented along with a comparison with a commercially available mandibular locking fixation plate (MODUS(®) TriLock(®) 2.0/2.3/2.5, Medartis AG, Basel, Switzerland). The proposed designs resulted in a statistically significant improvement in the available bone thickness when compared to the standard plate. There is a higher probability that the proposed implants cover areas of thicker cortical bone without compromising the bone mineral density around the screws. The obtained results allowed us to conclude that an angle and screw separation of 129° and 9 mm for females and 121° and 10 mm for males are more suitable designs than the commercially available 120° and 9 mm.

Loss of alpha10beta1 integrin expression leads to moderate dysfunction of growth plate chondrocytes

Integrin alpha10beta1 is a collagen-binding integrin expressed on chondrocytes. In order to unravel the role of the alpha10 integrin during development, we generated mice carrying a constitutive deletion of the alpha10 integrin gene. The mutant mice had a normal lifespan and were fertile but developed a growth retardation of the long bones. Analysis of the skeleton revealed defects in the growth plate after birth characterized by a disturbed columnar arrangement of chondrocytes, abnormal chondrocyte shape and reduced chondrocyte proliferation. Electron microscopy of growth plates from newborn mice revealed an increased number of apoptotic chondrocytes and reduced density of the collagen fibrillar network compared to these structures in control mice. These results demonstrate that integrin alpha10beta1 plays a specific role in growth plate morphogenesis and function.