The success of cementless orthopaedic implants relies on bony ingrowth and active bone remodelling. Much research effort is invested to develop implants with controllable surface roughness and internal porous architectures that encourage these biological processes. Evaluation of these implants requires long-term and costly animal studies, which do not always yield the desired outcome requiring iteration. The aim of our study is to develop a cost-effective method to prescreen design parameters prior to animal trials to streamline implant development and reduce live animal testing burden. Ex vivo porcine cancellous bone cylinders (n=6, Ø20×12mm) were extracted from porcine knee joints with a computer-numerically-controlled milling machine under sterile conditions within 4 hours of animal sacrifice. The bone discs were implanted with Ø6×12mm additive manufactured porous titanium implants and were then cultured for 21days. Half underwent static culture in medium (DMEM, 10% FBS, 1% antibiotics) at 37°C and 5% CO2. The rest were cultured in novel high-throughput stacked configuration in a bioreactor that simulated physiological conditions after surgery: the fluid flow and cyclic compression force were set at 10ml/min and 10–150 N (1Hz,5000 cycles/day) respectively. Stains were administered at days 7 and 14. Samples were evaluated with widefield microscopy, scanning electron microscopy (SEM) and with histology. More bone remodelling was observed on the samples cultured within the bioreactor: widefield imaging showed more remodelling at the boundaries between the implant-bone interface, while SEM revealed immature bone tissue integration within the pores of the implant. Histological analysis confirmed these results, with many more trabecular struts with new osteoid formation on the samples cultured dynamically compared to static ones. Ex vivo bone can be used to analyse new implant technologies with lower cost and ethical impact than animal trial. Physiological conditions (load and fluid flow) promoted bone ingrowth and remodelling.
Unicompartmental and total knee arthroplasty (UKA and TKA) are successful treatments for osteoarthritis, but monolithic implants disrupt the natural homeostasis of bone which leads to bone loss over time. This can cause problems if the implant needs to be revised. This study aimed to demonstrate that tibial implants made from titanium lattice could replace the tibial condyle surface while minimising disruption of the bone's natural mechanical loading environment. A secondary aim was to determine whether implants perform better if they replicate more closely bone's mechanical modulus, anisotropy and spatial heterogeneity. This study was conducted in a human cadaveric model. In a cadaveric model, UKA and TKA procedures were performed on 8 fresh-frozen knee specimens by a board-certified consultant orthopaedic surgeon, using tibial implants made from conventional monolithic material and titanium lattice structures. Stress at the bone-implant interfaces was measured with pressure film and compared to the native knee.Abstract
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OSSTEC is a pre-spin-out venture at Imperial College London seeking industry feedback on our orthopaedic implants which maintain bone quality in the long term. Existing orthopaedic implants provide successful treatment for knee osteoarthritis, however, they cause loss of bone quality over time, leading to more dangerous and expensive revision surgeries and high implant failure rates in young patients. OSSTEC tibial implants stimulate healthy bone growth allowing simple primary revision surgery which will provide value for all stakeholders. This could allow existing orthopaedics manufacturers to capture high growth in existing and emerging markets while offering hospitals and surgeons a safer revision treatment for patients and a 35% annual saving on lifetime costs. For patients, our implant technology could mean additional years of quality life by revising patients to a primary TKA before full revision surgery. Our implants use patent-filed additive manufacturing technology to restore a healthy mechanical environment in the proximal tibia; stimulating long term bone growth. Proven benefits of this technology include increased bone formation and osseointegration, shown in an animal model, and restoration of native load transfer, shown in a human cadaveric model. This technology could help capture the large annual growth (24%) currently seen in the cementless knee reconstruction market, worth $1.2B. Furthermore, analysis suggests an additional market of currently untreated younger patients exists, worth £0.8B and growing by 18% annually. Making revision surgery and therefore treatment of younger patients easier would enable access to this market. We aim to offer improved patient treatment via B2B sales of implants to existing orthopaedic manufacturer partners, who would then provide them with instrumentation to hospitals and surgeons. Existing implant materials provide good options for patient treatments, however OSSTEC's porous titanium structures offer unique competitive advantages; combining options for modular design, cementless fixation, initial bone fixation and crucially long term bone maintenance. Speaking to surgeons across global markets shows that many surgeons are keen to pursue bone preserving surgeries and the use of porous implants. Furthermore, there is a growing demand to treat young patients (with 25% growth in patients younger than 65 over the past 10 years) and to use cementless knee treatments, where patient volume has doubled in the past 4 years and is following trends in hip treatments. Our team includes engineers and consultant surgeons who have experience developing multiple orthopaedic implants which have treated over 200,000 patients. To date we have raised £175,000 for the research and development of these implants and we hope to gain insight from industry professionals before further development towards our aim to begin trials for regulatory approval in 2026. OSSTEC implants provide a way to stimulate bone growth after surgery to reduce revision risk. We hope this could allow orthopaedic manufactures to explore high growth markets while meaning surgeons can treat younger patients in a cost effective way and add quality years to patients' lives.
This study aids the control of remodelling and strain response in bone; providing a quantified map of apparent modulus and strength in the proximal tibia in 3 anatomically relevant directions in terms of apparent density and factor groups. 7 fresh-frozen cadaveric specimens were quantified computed tomography (qCT) scanned, segmented and packed with 3 layers of 9mm side length cubic cores aligned to anatomical mechanical axes. Cores were removed with printed custom cutting and their densities found from qCT. Cores (n = 195) were quasi-statically compression tested. Modulus was estimated from a load cycle hysteresis loop, between 40% and 20% of yield stress. Sequential testing order in 3 orthogonal directions was randomised. Group differences were identified via an analysis of variance for the factors density, age, gender, testing order, subchondral depth, condyle and sub-meniscal location. Regression models were fit for significant factor sub-groups, predicting properties from density.Abstract
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Integrating additively manufactured structures, such as porous lattices into implants has numerous potential benefits, such as custom mechanical properties, porosity for osseointegration/fluid flow as well as improved fixation features. Component anisotropic stiffness can be controlled through varying density and lattice orientation. This is useful due to the influence of load on bone remodelling. Matching implant and bone anisotropy/stiffness may help reduce problems such as stress shielding and prevent implant loosening. It is therefore beneficial to be able to design AM parts with a desired anisotropic stiffness. In this study we present a method that predicts the anisotropic stiffness of an additively manufactured lattice structure from its CAD data, and validate this model with experimental testing. The model predicts anisotropic stiffness in terms of density (ρ), fabric (
A stochastic line structure was formed in CAD by joining pseudo-random points generated using the Poisson-disk method Lines at an angle lower than 30° to the x-y plane removed to allow for AM manufacturing. Lines were converted to struts with 330 µm diameter. Second order fabric tensors were determined from CAD files of the AM specimens using the mean intercept length (MIL), the gold standard for determining a measure of the ‘average orientation’ of material within trabecular bone structures. 10 × 10 × 12 mm specimens of the CAD model were manufactured on a Renishaw AM250 powder bed fusion machine. The structure was built in 10 different orientations to enable stiffness measurement in 10 different directions (n=5 for each direction). Compression testing in a servohydraulic materials testing machine was performed according to ISO13314 with LVDTs used to measure displacement to remove compliance effects. Stress-strain curves were obtained and elastic moduli were estimated from a hysteresis loop in the load application, from 70% to 20% of the plateau stress. Specimen density and fabric data were fit to the observed stiffnesses using least squares linear regression. Experimental stiffnesses of the structure in 10 directions were compared to the model to evaluate the accuracy of model predictions.Introduction
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