Philip Procter

Intramedullary femoral nails: one or two lag screws? A preliminary study

Failures of proximal femoral nails that treat unstable femoral fractures have been reported. In this communication, a finite element model to include a proximal femoral nail within a fractured femur was used to carry out preliminary investigations into configurations of single or double lag screws. The effects of the different types of fracture were investigated. The results show that in order to share the load evenly between two lag screws, a good configuration seems to be to have a slightly larger screw above the lower screw. This also ameliorates stresses in the nail at the lag screw insertion holes. However, using two screws in this way can lead to large stresses in the cancellous bone in the femoral head, and these stresses may be significant in the initiation of cut-out.

Calcium phosphate cement augmentation of cancellous bone screws can compensate for the absence of cortical fixation.

An obvious means to improve the fixation of a cancellous bone screw is to augment the surrounding bone with cement. Previous studies have shown that bone augmentation with Calcium Phosphate (CaP) cement significantly improves screw fixation. Nevertheless, quantitative data about the optimal distribution of CaP cement is not available. The present study aims to show the effect of cement distribution on the screw fixation strength for various cortical thicknesses and to determine the conditions at which cement augmentation can compensate for the absence of cortical fixation in osteoporotic bone. In this study, artificial bone materials were used to mimic osteoporotic cancellous bone and cortical bone of varying thickness. These bone constructs were used to test the fixation strength of cancellous bone screws in different cortical thicknesses and different cement augmentation depths. The cement distribution was measured with microCT. The maximum pullout force was measured experimentally. The microCT analysis revealed a pseudo-conic shape distribution of the cement around the screws. While the maximum pullout strength of the screws in the artificial bone only was 30±7N, it could increase up to approximately 1000N under optimal conditions. Cement augmentation significantly increased pullout force in all cases. The effect of cortical thickness on pullout force was reduced with increased cement augmentation depth. Indeed, cement augmentation without cortical fixation increased pullout forces over that of screws without cement augmentation but with cortical fixation. Since cement augmentation significantly increased pullout force in all cases, we conclude that the loss of cortical fixation can be compensated by cement augmentation.

Injectable calcium phosphate cement for augmentation around cancellous bone screws. In vivo biomechanical studies.

In lower cancellous apparent bone density, it can be difficult to achieve adequate screw fixation and hence stable fracture fixation. Different strategies have been proposed, one of them is through augmentation using calcium phosphate cement in the region at or close to the screw thread itself. To support the hypothesis of an improved screw fixation technique by augmentation of the bone surrounding the implanted screw, in vivo biomechanical and densitometric studies are performed on rabbit specimen where normal and simulated weak bone quality are considered. In particular, the evolution of screw stability till 12 weeks following the implantation is quantified. A statistical significance in the pull out force for augmented versus non-augmented screws was found for the shorter time periods tested of ≤ 5 days whilst the pull out force was found to increase with time for both augmented and non-augmented screws during the 12 week course of the study. The results of the study demonstrate that the use of an injectable calcium phosphate cement which sets in vivo can significantly improve screw pull out strength at and after implantation for normal and simulated weak bone quality.

In vivo assessment of local effects after application of bone screws delivering bisphosphonates into a compromised cancellous bone site

BACKGROUND The primary stability of cancellous screw is difficult to obtain in bone of compromised quality and failure of screw fixation is common. To overcome this problem, it is proposed to locally deliver bisphosphonate from the screw. An in vivo validation of the increase in fixation of the cancellous screw is then needed in compromised bone. METHODS In this study, we used an overdrilling procedure, which enables consistent modeling of reduced screw stability comparable to compromised cancellous bone. Forty eight adult NZW rabbits were used in this study and all animals underwent bilateral femur implantation. One leg was implanted with the screw containing the bisphosphonate (biocoated group) while the other was used as control (control group) with the screw only. Mechanical testing and micro-CT imaging were used to assess the effect of local drug delivery of Zoledronate on screws fixation at 5 time points. FINDINGS At the early time points (1, 5, and 10 days), no significant difference could be seen between the biocoated and control groups. At 6 weeks, the bone volume fraction was significantly higher in the trabecular region of the biocoated group. However, this increase did not have a significant effect on the pull-out force. At the last time point, 11 weeks, both the bone volume fraction and the pull-out force were significantly higher in the biocoated group. INTERPRETATION The results of this study suggest that, in compromised bone, local delivery of bisphosphonate enhances the stability of bone screws.

Optimising implant anchorage (augmentation) during fixation of osteoporotic fractures: Is there a role for bone-graft substitutes?

When stabilising a fracture the contact between the screw and the surrounding bone is crucial for mechanical strength. Through development of screws with new thread designs, as well as optimisation of other properties, improved screw purchase has been gained. Other alternatives to improve screw fixation in osteoporotic bone, as well as normal bone if needed, includes the use of various coatings on the screw that will induce a bonding between the implant surface and the bone implant, as well as application of drugs such as bisphosphonates locally in the screw hole to induce improved screw anchorage through their anticatabolic effect on the bone tissue. As failure of internal fixation of fractures in osteoporotic bone typically occurs through breakage of the bone that surrounds the implant, rather than the implant itself, an alternative strategy in osteoporotic bone can include augmentation of the bone around the screw. This is useful when screws alone are being used for fixation, as it will increase pull-out resistance, but also when conventional plates and screws are used. In angularly stable plate-screw systems, screw back-out is not a problem if the locking mechanism between the screws and the plate works. However, augmentation that will strengthen the bone around the screws can also be useful in conjunction with angle-stable plate-screw systems, as the augmentation will provide valuable support when subjected to loading that might cause cut-out. For many years conventional bone cement, polymethylmethacrylate (PMMA), has been used for augmentation, but due to side effects--including great difficulties if removal becomes necessary--the use of PMMA has never gained wide acceptance. With the introduction of bone substitutes, such as calcium phosphate cement, it has been shown that augmentation around screws can be achieved without the drawbacks seen with PMMA. When dealing with fixation of fractures in osteoporotic bone where screw stability might be inadequate, it therefore seems an attractive option to include bone substitutes for augmentation around screws as part of the armamentarium. Clinical studies now are needed to determine the indications in which bone augmentation with bone-graft substitutes (BGSs) would merit clinical usage.

Does locally delivered Zoledronate influence peri-implant bone formation? – Spatio-temporal monitoring of bone remodeling in vivo

Bisphosphonates are known for their strong inhibitory effect on bone resorption. Their influence on bone formation however is less clear. In this study we investigated the spatio-temporal effect of locally delivered Zoledronate on peri-implant bone formation and resorption in an ovariectomized rat femoral model. A cross-linked hyaluronic acid hydrogel was loaded with the drug and applied bilaterally in predrilled holes before inserting polymer screws. Static and dynamic bone parameters were analyzed based on in vivo microCT scans performed first weekly and then biweekly. The results showed that the locally released Zoledronate boosted bone formation rate up to 100% during the first 17 days after implantation and reduced the bone resorption rate up to 1000% later on. This shift in bone remodeling resulted in an increase in bone volume fraction (BV/TV) by 300% close to the screw and 100% further away. The double effect on bone formation and resorption indicates a great potential of Zoledronate-loaded hydrogel for enhancement of peri-implant bone volume which is directly linked to improved implant fixation.

Biomechanical and antibacterial properties of Tobramycin loaded hydroxyapatite coated fixation pins

The present study investigates the use of nanoporous, biomimetic hydroxyapatite (HA) coatings deposited on TiO₂ coated fixation pins as functional implant surfaces for the local release of Tobramycin in order to prevent bacterial colonization. The impact of HA-coating thickness, coating morphology and biomechanical forces during insertion into synthetic bone on the drug loading and release properties are analyzed. The coatings are shown to exhibit bactericidal effects against Staphylococcus aureus in agar medium for a duration of 6 days after loading by adsorption with Tobramycin for only 5 min at elevated temperature and pressure. Furthermore, high performance liquid chromatography analysis shows a drug release in phosphate buffered saline for 8 days with antibiotic concentration remaining above the minimal inhibitory concentration for S. aureus during the entire release period. Biomechanical insertion tests into synthetic bone and conventional scratch testing demonstrate adhesive strength at the HA/TiO₂ interface. Biocompatibility is verified by cell viability tests. Outgrowth endothelial cells, as well as primary osteoblasts, are viable and firmly attached to both HA and TiO₂ surfaces. The results presented are encouraging and support the concept of functional HA coatings as local drug delivery vehicles for biomedical applications to treat as well as to prevent post-surgical infections.

Finite element analysis of intramedullary devices: the effect of the gap between the implant and the bone.

This paper examines the interaction interface between the implant and the bone for an intramedullary femoral nailing system using a finite element (FE) model and specifically considers the hypothesis that the local geometry at the interface is significant to the resulting localized contact stress between the medial and lateral aspect of nail and endosteum. Contact mechanics algorithms are used in the FE modelling technique that can be developed to deal with any form of intramedullary device for which contact at the bone—implant interface is important. Global stiffness data from the FE model are compared with available data from an experiment carried out on a construct of the bone and the device that uses intramedullary femoral nails. Acceptable agreement is obtained. The results demonstrate that the mechanical interface between the implant and the bone is significantly affected by the gap geometry and magnitude. In particular, larger gaps lead to greater concentrations of stress on the medial side, while the distribution of stress is more uniform at the lateral contacts. Furthermore, the results show that the gap can have a marked effect on the stresses that occur on the fracture plane.

Co-precipitation of Tobramycin into Biomimetically Coated Orthopedic Fixation Pins Employing Submicron-Thin Seed Layers of Hydroxyapatite

The migration, loosening and cut-out of implants and nosocomial infections are current problems associated with implant surgery. New innovative strategies to overcome these issues are emphasized in todays research. The current work presents a novel strategy involving co-precipitation of tobramycin with biomimetic hydroxyapatite (HA) formation to produce implant coatings that control local drug delivery to prevent early bacterial colonization of the implant. A submicron- thin HA layer served as seed layer for the co-precipitation process and allowed for incorporation of tobramycin in the coating from a stock solution of antibiotic concentrations as high as 20 mg/ml. Concentrations from 0.5 to 20 mg/ml tobramycin and process temperatures of 37 °C and 60 °C were tested to assess the optimal parameters for a thin tobramycin- delivering HA coating on discs and orthopedic fixation pins. The morphology and thickness of the coating and the drug-release profile were evaluated via scanning electron microscopy and high performance liquid chromatography. The coatings delivered pharmaceutically relevant amounts of tobramycin over a period of 12 days. To the best of our knowledge, this is the longest release period ever observed for a fast-loaded biomimetic implant coating. The presented approach could form the foundation for development of combination device/antibiotic delivery vehicles tailored to meet well-defined clinical needs while combating infections and ensuring fast implant in-growth.

Bone substitute materials delivering zoledronic acid: Physicochemical characterization, drug load, and release properties

Calcium phosphate-like bone substitute materials have a long history of successful orthopedic applications such as bone void filling and augmentation. Based on the clinical indications, these materials may be loaded with active agents by adsorption offering a perspective for providing innovative drug-delivery systems. The highly effective bisphosphonate zoledronic acid (ZOL) demonstrated a strong affinity to biominerals and is known to significantly reduce osteoclastic activity. Support of early bone formation and reduction of bone resorption can be promoted after implantation of bioceramics releasing ZOL. The aim of this study was to develop an easy to handle approach to combine ZOL with bone substitutes by use of a dipping technique. The properties of three different materials were investigated by using a number of physicochemical methods such as light microscopy, scanning electron microscopy (SEM), dynamic vapor sorption (DVS), true density, and surface area measurement to evaluate the feasibility of being potential drug carriers. Besides physicochemical characterization, the bone substitutes were evaluated by their ZOL-loading capacity in a time- and concentration-dependent manner. Additionally, the materials were assessed as release systems in an in vitro study. Acontrolled ZOL load in a range of 0.04–1.86 µg/mg material and a release of 0.02–0.18 µg/mg within 30 min is demonstrated. The findings support using the investigated bioceramics as carrier systems to release ZOL. Overall, the results create the base for further development of drug-delivery systems with controlled drug loading and prolonged release and need to be further analyzed in an in vivo study.