Intramedullary nailing is the standard fixation method for displaced diaphyseal fractures of the tibia in adults. Anecdotal clinical evidence indicates that current nail designs do not fit optimally for Asian patients. This study aimed to develop a method to quantitatively assess the fitting of two nail designs for Asian tibiae.

We used 3D models of two different tibial nail designs (ETN (Expert Tibia Nail) and ETN-Proximal-Bend, Synthes), and 20 CT-based 3D cortex models of Japanese cadaver tibiae. The nail models were positioned inside the medullary cavity of the intact bone models. The anatomical fitting between nail and bone was assessed by the extent of the nail protrusion from the medullary cavity into the cortical bone, which in a real bone would lead to axial malalignments of the main fragments. The fitting was quantified in terms of the total surface area, and the maximal distance of nail protrusion.

In all 20 bone models, the total area of the nail protruding from the medullary cavity was smaller for the ETN-Proximal-Bend (average 540 mm2) compared to the ETN (average 1044 mm2). Also, the maximal distance of the nail protruding from the medullary cavity was smaller for the ETN-Proximal-Bend (average 1.2 mm) compared to the ETN (average 2.7 mm). The differences were statistically significant (p < 0.05) for both the total surface area and the maximal distance measurements. For all bone models, the nail protrusion occurred on the posterior side in the middle third of the tibia. For 12 bones the protrusion was slightly lateral to the centre of the shaft, for seven bones it was centred, and for one bone it was medial to the shaft. The ETN-Proximal-Bend shows a statistical significantly better intramedullary fit with less cortical protrusion than the original ETN. The expected clinical implications of an improved anatomical nail fit are fewer complications with malreduction and malalignments, a lower likelihood for fracture extension and/or new fracture creation during the nail insertion as well as an easier handling for the nail insertion.

By utilising computer graphical methods we were able to conduct a quantitative fit assessment between implanted nail and bone geometry in 3D. In addition to the application in implant design, the developed method could potentially be suitable for pre-operative planning enabling the surgeon to choose the most appropriate nail design.

To elucidate the molecular biology of fracture healing, murine models are preferred. We performed a study with the first internal fixation system that allows studying murine fracture healing in a controlled mechanical environment, to characterise the timing of the fracture healing cascade with this model, based on a histological evaluation.

Femoral osteotomies were performed in 68 male C57BL/six mice and stabilised with locking internal fixation plates in either stiff, or defined, flexible configurations. Healing progression was studied at 10 time points between 3 and 42 days post- surgery. After surgery, mice were radiographed to confirm the correct implant positioning. After sacrifice, the extracted femora were processed for decalcified histology. Thin sections were taken as serial transverse sections and stained for subsequent histomorphometric analysis and three-dimensional reconstruction of the different fracture callus tissues.

The surgery was successful in 62 animals. Only six6 (8.8%) animals had to be sacrificed due to complications during surgery. The post-operative radiographs demonstrated a high reproducibility of implant positioning and no implant failure or screw loosening occurred during the experimental period. The improved consistency in surgical technique leading to more uniform results represents a key advantage of this system over other mouse fracture healing models. As such, it may allow a reduction in the sample size needed in future murine fracture healing studies. The histological evaluation confirmed the lack of a periosteal callus, and exclusively endosteal, intramembraneous bone formation in the bones stabilised with the stiff implants. The bones that were stabilised with the more flexible internal fixation plates showed additional endochondral ossification with extensive, highly asymmetrical, periosteal callus formation.

Our results demonstrate that this murine fracture model leads to different healing patterns depending on the flexibility of the chosen plate system. This allows researchers to investigate the molecular biology of fracture healing in different ossification modes by selection of the appropriate fixation.

Introduction: With the development and popularisation of minimally invasive surgical methods and implants, it is increasingly important that available implants are pre-contoured to the specific anatomical location for which they are designed. From a clinical point of view, an anatomically well fitting plate can greatly facilitate the process of closed reduction in terms of axial and rotational alignment of the main fragments. Furthermore, such a plate may additionally protrude less and therefore minimise soft tissue irritations. Clinical practice and recent research shows that some of the current pre-contoured fracture fixation plates do not fit well for certain patient groups ^1,2. This study reports on a method for optimising the shape of a plate for a given dataset.

Methods: Forty-five 3D models of the outer bone contour of Japanese tibiae were generated from CT image data. The fit between bone models and the undersurface (bone facing) of a distal medial tibia plate was quantified using the reverse engineering software RapidForm2006 (Inus Technology Inc., Korea). An anatomical fit of the plate was defined with four criteria². The current plate shape was optimised in the virtual environment using computer graphical tools of RapidForm2006.

Results: The current plate shape achieved an anatomical fit on 13% of tibias from the dataset, whereas the modified plate achieved an anatomical fit for 67% of the bone models.

Conclusion: Computer graphical methods enable optimisation of the shape of an existing plate resulting in a significantly improved fitting for the bones of the available dataset.

Introduction: It has long been recognised that static plain x-rays are a sub-optimal method for the assessment of lumbar fusion. Blumenthal and Gil showed that radiographic assessment of fusion corresponded with operative findings only 69% of the time. Santos et al suggest that both plain x-rays and flexion/extension x-rays overestimate the fusion rate when compared to helical computed tomography (CT). To date there has been no correlation of CT assessment of fusion with surgical exploration. In this study we present an animal model of lumbar spine pseudarthrosis and compare three imaging modalities with micro-cut CT scanning and cadaveric assessment.

Methods: Approval was gained from the QUT animal ethics committee. Eleven mixed bred ewes were assigned to either a fusion group or an intentional pseudarthrosis (IP) group. A dorsal approach to the facet joints of L2/3 was made. The facet joints were destabilised by resecting the articulating surfaces with a rongeur. In the fusion group, the spinous processes of the destabilised segment were wired tightly together and a bone graft harvested from the iliac crest was placed into the joint space. In the IP group the bone graft bed was prepared similarly except that a small proportion of the articulating surface was left intact and a 1.0 cm2 roll of oxidised cellulose was placed into the facet joint space bilaterally. In the IP group the spinous processes were wired around an interspinous spacer which was later removed to create a similar degree of laxity in the fixation of each of the IP specimens. The animals were sacrificed at 6 months and static and dynamic lateral radiographs obtained. The spine was removed en bloc, and high speed fine cut (2mm) CT Scanning performed. The specimens were individually assessed for fusion by micro-cut CT scanning. Eight independent, blinded orthopaedic surgeons, were asked whether they considered the spine to be fused based on

plain x-ray

These results were correlated with a fusion rate based on the micro CT. The specificity and sensitivity of these radiological measures in diagnosing pseudarthrosis and inter-rater reliability using Fleiss’ Kappa scores for each method were calculated.

Results: For assessing pseudarthrosis identified by microCT the plain film sensitivity was 0.41 and the specificity was 0.47. For assessing pseudarthrosis with plain and flexion extension xrays the sensitivity was 0.55 and the specificity was 0.33. For assessing pseudarthrosis with plain flexion extension xrays and CT the sensitivity was 0.81 and the specificity was 0.88. The Kappa score for plain films was 0.15, for flexion extension was 0.07 and CT was 0.54.

Discussion: This study suggests that plain radiographs and flexion extension radiographs are an unreliable measure of posterior lumbar fusion. The current clinical gold standard for assessment of fusion (CT) was able to correctly identify non-union in 80% of cases. Whilst no alternatives to structural assessment of the fusion mass with CT currently exist it is important to recognise the limitations of this technique.

Volume and density of fracture callus are important outcome parameters in fracture healing studies. These values provide an indication for the recovery of the mechanical function of the bone. Traditionally, fracture callus’ have been evaluated from radiographs, which represent 2D projections of the three-dimensional structures, therefore such an analysis can be affected by many artefacts. With the availability of Computer Tomography (CT) scanners for the evaluation of healing bones, it is now possible to perform precise, three-dimensional reconstructions of the fracture callus and therefore to evaluate true three-dimensional callus volumes and bone mineral densities. We wanted to make use of this technology in the evaluation of a study looking at the healing of a multifragmentary fracture in sheep after 4 and 8 weeks of healing time (Wullschleger et al, ANZORS, 2006). Our goal was to develop a protocol that would allow for the standardised calculation of cortical bone and callus tissue volumes with minimal user influence. Here, we report on the development of this evaluation protocol and some early results.

A clinical CT scanner was used to scan the experimental limbs, immediately after the sheep had been euthanized. Further analysis of the CT dataset was accomplished with the commercial computer software Amira. The region of interest was cropped to a 9 cm section of the bone shaft, guaranteed to comprise the entire fracture callus. Next, the cortical bone and the callus tissue were segmented by choosing appropriate threshold values for the measured grey levels. The volume of the segmented regions was then calculated by the software.

The application of this protocol to six CT scans from our experimental study resulted in average callus volumes of 12.21 ± 1.96 (standard deviation) cm2 after 4 weeks healing time and 14.28 ± 1.58 cm2 after 8 weeks healing time.

In conclusion, we demonstrated the feasibility of using CT data for a quantitative 3D analysis of callus volumes. While this technique is undoubtedly superior to the estimation of callus volumes from two-dimensional radiographs, the absolute accuracy of the results will need to be determined by comparison with histological data.

Bilateral mandibular lengthening is widely accepted during mandibular distraction osteogenesis. However, distraction osteogenesis are sometimes associated with clinical complications such as open bite deformity, lateral displacement of temporo-mandibular joint, premature consolidation and pin loosening. Although distraction osteogenesis aims to develop pure tensile strain on the regenerate tissue however, in real life situation due to differences in device orientation, materials and misalignment it is often subjected to complex stress and strain regimes.

The objective of this study was to characterise the mechanical environment (stress and strain) in the Finite Element Models (FEM) of regenerate tissue during two different device orientations:

(a) device placed parallel to the mandibular body

Furthermore, the influence of misalignment from above two idealised orientations was also investigated.

The distraction protocol in this study was similar to previous study of Loboa et al (2005). FE models were developed at four stages: end of latency, distraction day two, distraction day five and distraction day eight. At each time period a distraction of 1mm was applied to the model as it is most widely used distraction rate. In these models two primary distraction vectors were simulated; first when the device is parallel to the body of the mandible and second when the device is parallel to the axis of distraction.

Results indicate that when the device is placed parallel to the mandible the effect of distraction vector variation due to misalignment in transverse plane (±150 at an interval of 50 ; + indicate lateral and indicates medial) is symmetric and variation in the stress and strain regimes on regenerative tissue are less than 3%. However, when the device is placed parallel to axis of distraction the corresponding change is asymmetric and almost double in magnitude. The greatest differences were seen when misalignment is towards lateral side (+150). Similarly in the sagittal plane variations up to 17% were developed due to 0- 400 change in the distraction vector orientation. Thus the orientation of device which determines the distraction vector plays an important role in determining the mechanical environment around regenerative tissue. The results suggest that implications of misalignment of the device and its sensitivity from the ideal situation should be well understood during clinical planning.

With the development and popularisation of minimally invasive surgical methods and implants for fracture fixation, it is increasingly important that available implants are pre-contoured to the specific anatomical location for which they are designed. Due to differences in the bone morphology it is impossible to design single implants that are universally applicable for the entire human population. A recent study on the fit of a distal periarticular medial tibia plate to Japanese bones supported the need for shape optimisation [1]. The present study aimed to quantify and optimise the fit of the same plate for an extended dataset of Japanese tibiae.

Forty-five 3D models of the outer bone contour of Japanese tibiae were used. The average age of the specimens was 67 years with an average height of 156 cm. All bone models were considered to be within a normal range without any bony pathology. An anatomical fit of the plate was defined with four criteria [1]. The current plate shape was optimised based on the quantitative results of the plate fitting. Two different optimised plate shapes were generated.

The current plate shape achieved an anatomical fit on 13% of tibias from the dataset. Plate 1 achieved an anatomical fit for 42% and Plate 2 a fit for 67% of the bone models. If either Plate 1 or Plate 2 is used, then the anatomical fit can be increased from 13% to 82% for the same dataset. For 12 (27%) of the 45 bones both modified plate shapes were fitting.

The results for the fit of the current plate shape are comparable to findings of a similar study on the anatomical fitting of proximal tibia plates [2]. The obtained results indicate that for the available dataset no further modification is warranted for the shaft region of the modified plates. Further optimization of the distal regions of Plate 1 and Plate 2 will be possible. This study shows that in order to achieve an anatomical fit of the plate to the medial Malleolus at least two different plate shapes will be required.

In recent years, plate osteosynthesis in metaphyseal and diaphyseal long bone fractures has been increasingly applied in a minimally invasive fashion. Several clinical studies describe a beneficial effect of the smaller additional soft tissue damage, resulting in satisfying fracture and soft tissue healing. However, is the surgical soft tissue damage really evidently smaller and the recovery faster?

A trauma model with severe, circumferential soft tissue damage to the distal right thigh and a distal multifragmentary (AO type C) femur fracture was carried out on 24 male sheep. After five days temporary external fixation, an internal fixator was placed either by a conventional open lateral approach or by minimally invasive technique. To assess the soft tissue damage and its recovery within the first 14 days, local compartment pressure monitoring as well as daily measurements of systemic markers (Creatin Kinase, CK and Lactate Dehydrogenase, LDH) in blood were performed. The local monitoring with a special probe (Neurovent PTO, Raumedic AG, Germany) within the quadriceps muscle allowed the measurement of compartment pressure (CP), as well as temperature.

The CK and LDH levels responded to the severe trauma with high peaks within the first 48 hours post trauma. After the internal fixator operations CK levels illustrate a significantly lower increase (p< 0.05) in the minimally invasive group compared to the open approach group in the first two days postoperatively. LDH levels show lower values for the minimally invasive group (p=0.06).

The values of CP present an initial increase after the trauma and then higher values (p=0.08) after the open plating operation. For the intracompartmental temperature no statistical differences were found, too (p=0.17).

These results, with reduced additional soft tissue damage and faster recovery in the minimally invasive approach group, reflect the clinical experience and expectations. However, while minimally invasive plate osteo-synthesis is certainly a desired option for fracture fixation, good surgical skills are required to insure that the reduced surgical trauma is in line with optimal fracture healing. The influence of the two different approaches on the bone healing per se, as well as the influence on soft tissue functionality, has yet to be demonstrated.

Volume and density of fracture callus are important outcome parameters in fracture healing studies. These values provide an indication for the recovery of the mechanical function of the bone. Traditionally, fracture callus’ have been evaluated from radiographs, which represent 2D projections of the three-dimensional structures; therefore such an analysis can be affected by many artefacts. With the availability of Computer Tomography (CT) scanners for the evaluation of healing bones, it is now possible to perform precise, three-dimensional reconstructions of the fracture callus and therefore to evaluate true three-dimensional callus volumes and bone mineral densities. We wanted to make use of this technology in the evaluation of a study looking at the healing of a multifragmentary fracture in sheep after 4 and 8 weeks of healing time (Wullschleger et al, ANZORS, 2006). Our goal was to develop a protocol that would allow for the standardised calculation of cortical bone and callus tissue volumes with minimal user influence. Here, we report on the development of this evaluation protocol and some early results.

A clinical CT scanner was used to scan the experimental limbs, immediately after the sheep had been euthanized. Further analysis of the CT dataset was accomplished with the commercial computer software Amira. The region of interest was cropped to a 9 cm section of the bone shaft, guaranteed to comprise the entire fracture callus. Next, the cortical bone and the callus tissue were segmented by choosing appropriate threshold values for the measured grey levels. The volume of the segmented regions was then calculated by the software.

The application of this protocol to six CT scans from our experimental study resulted in average callus volumes of 12.21 ± 1.96 (standard deviation) cm2 after 4 weeks healing time and 14.28 ± 1.58 cm2 after 8 weeks healing time.

In conclusion, we demonstrated the feasibility of using CT data for a quantitative 3D analysis of callus volumes. While this technique is undoubtedly superior to the estimation of callus volumes from two-dimensional radiographs, the absolute accuracy of the results will need to be determined by comparison with histological data.