Summary. Osseointegrated Amputation Prostheses can be functionalised by both biological augmentation and structural augmentation. These augmentation techniques may aid the formation of a stable skin-implant interface. Introduction. Current clinical options are limited in restoring function to amputees, and are associated with contact dermatitis and infection at the stump-socket interface. Osseointegrated Amputation Prosthesis attempts to solve issues at the stump-socket interface by directly transferring axial load to the prosthesis, via a skin-penetrating abutment. However, development is needed to achieve a seal at the skin-implant interface to limit infection. Fibronectin, an Extracellular Matrix protein, binds to integrins during wound healing, with the RGD tripeptide being part of the recognition sequence for its integrin binding domain. In vitro work has found silanization of RGD to polished titanium discs up regulates fibroblast attachment compared to polished control. Electron Beam Melting can produce porous titanium alloy implants, which may encourage tissue attachment. This study aims to test whether a combination of biological RGD coatings and porous metal manufacturing techniques can encourage the formation of a seal at the skin-implant interface. Materials and Methods. We developed four different augmented transcutaneous devices: Porous, Porous RGD coated, drilled and drilled RGD coated. These were implanted in tibial transcutaneous ovine model, n=6, for a period of 6 months. Following explantation we performed hard grade resin histology to assess soft tissue attachment at the transcutaneous interface. Results. Histological analysis revealed no statistical difference in epithelial downgrowth and epidermal attachment values between the four augmented devices. There were significant increases (p<0.05) in the number of blood vessels and the number of cells in the Porous RGD devices compared with both drilled implant devices. Both Porous and Porous RGD implant groups observed significant increase (p<0.05) in soft tissue infiltration compared with both Drilled implant devices. Discussion. The use of porous structures and RGD coatings increases tissue ingrowth and revascularisation in ITAP devices despite having no effect on epithelial downgrowth and epidermal attachment in a long-term ovine model. There were no detrimental effects in the transcutaneous interface formation observed. These augmentation techniques may prove beneficial in preclinical and clinical developments of transcutaneous osseointegrated devices

To try and aid the formation of a soft tissue seal to promote dermal and epidermal attachment to Intraosseous Transcutaneous Amputation Prostheses we compared the effect of titanium surfaces functionalised with fibronectin (fn) or YRGD peptide sequences on human dermal cell (HDF) attachment. We hypothesise that YRGD and fn coatings will significantly increase HDF attachment to titanium alloy substrates. Titanium alloy 10mm discs were polished and acted as control substrates, functionalised surfaces had YRGD or fn adsorbed or silanised onto the polished surface. HDFs were seeded at 10,000/disc and cultured for 1, 4, 24 and 96 hours, fixed and fluorescent immnolocalisation for vinculin was performed. Individual vinculin markers were counted and density calculated as a measure of cell attachment. All assays were performed in triplicate and data were analysed in SPSS 19.0 and results were considered significant at the 0.05 level. Results showed an up-regulation of Focal adhesion density (FA) against controls at all time-points (excluding ad-fn at 4 hours, p=0.057), p values < 0.05, the use of functionalised titanium surfaces may lead to long-term clinical success of ITAP. We have shown a significant positive effect on cell attachment when a synthetic peptide sequence is used. Using synthetic peptide sequence may also be more beneficial from a regulatory stand-point compared with using isolated proteins

Infection in orthopedics is a challenge, since it has high incidence (rates can be up to 15-20%, also depending on the surgical procedure and on comorbidities), interferes with osseointegration and brings severe complications to the patients and high societal burden. In particular, infection rates are high in oncologic surgery, when biomedical devices are used to fill bone gaps created to remove tumors. To increase osseointegration, calcium phosphates coatings are used. To prevent infection, metal- and mainly silver-based coatings are the most diffused option. However, traditional techniques present some drawbacks, including scarce adhesion to the substrate, detachments, and/or poor control over metal ions release, all leading to cytotoxicity and/or interfering with osteointegration. Since important cross-relations exist among infection, osseointegration and tumors, solutions capable of addressing all would be a breakthrough innovation in the field and could improve clinical practice.

Here, for the first time, we propose the use antimicrobial silver-based nanostructured thin films to simultaneously discourage infection and bone metastases. Coatings are obtained by Ionized Jet Deposition, a plasma-assisted technique that permits to manufacture films of submicrometric thickness having a nanostructured surface texture. These characteristics, in turn, allow tuning silver release and avoid delamination, thus preventing toxicity. In addition, to mitigate interference with osseointegration, here silver composites with bone apatite are explored. Indeed, capability of bone apatite coatings to promote osseointegration had been previously demonstrated in vitro and in vivo. Here, antibacterial efficacy and biocompatibility of silver-based films are tested in vitro and in vivo. Finally, for the first time, a proof-of-concept of antitumor efficacy of the silver-based films is shown in vitro.

Coatings are obtained by silver and silver-bone apatite composite targets. Both standard and custom-made (porous) vertebral titanium alloy prostheses are used as substrates.

Films composition and morphology depending on the deposition parameters are investigated and optimized. Antibacterial efficacy of silver films is tested in vitro against gram+ and gram- species (E. coli, P. aeruginosa, S. aureus, E. faecalis), to determine the optimal coatings characteristics, by assessing reduction of bacterial viability, adhesion to substrate and biofilm formation. Biocompatibility is tested in vitro on fibroblasts and MSCs and, in vivo on rat models. Efficacy is also tested in an in vivo rabbit model, using a multidrug resistant strain of S. aureus (MRSA, S. aureus USA 300). Absence of nanotoxicity is assessed in vivo by measuring possible presence of Ag in the blood or in target organs (ICP-MS). Then, possible antitumor effect of the films is preliminary assessed in vitro using MDA-MB-231 cells, live/dead assay and scanning electron microscopy (FEG-SEM). Statistical analysis is performed and data are reported as Mean ± standard Deviation at a significance level of p <0.05. Silver and silver-bone apatite films show high efficacy in vitro against all the tested strains (complete inhibition of planktonic growth, reduction of biofilm formation > 50%), without causing cytotoxicity. Biocompatibility is also confirmed in vivo.

In vivo, Ag and Ag-bone apatite films can inhibit the MRSA strain (>99% and >86% reduction against ctr, respectively). Residual antibacterial activity is retained after explant (at 1 month). These studies indicate that IJD films are highly tunable and can be a promising route to overcome the main challenges in orthopedic prostheses.

The anatomy of the femur shows a high inter-patient variability, making it challenging to design standard prosthetic devices that perfectly adapt to the geometry of each individual. Over the past decade, Statistical Shape Models (SSMs) have been largely used as a tool to represent an average shape of many three-dimensional objects, as well as their variation in shape. However, no studies of the morphology of the residual femoral canal in patients who have undergone an amputation have been performed. The aim of this study was therefore to evaluate the main modes of variation in the shape of the canal, therefore simulating and analysing different levels of osteotomy.

To assess the variability of the femoral canal, 72 CT-scans of the lower limb were selected. A segmentation was performed to isolate the region of interest (ROI), ranging from the lesser tip of the trochanter to the 75% of the length of the femur. The canals were then sized to scale, aligned, and 16 osteotomy levels were simulated, starting from a section corresponding to 25% of the ROI and up to the distal section. For each level, the main modes of variations of the femoral canal were identified through Principal Component Analysis (PCA), thus generating the mean geometry and the extreme shapes (±2 stdev) of the principal modes of variation.

The shape of the canals obtained from these geometries was reconstructed every 10 mm, best- fitted with an ellipse and the following parameters were evaluated: i) ellipticity, by looking at the difference between axismax and axismin; ii) curvature of the canal, calculating the arc of circumference passing through the shapes’ centroids; iii) conicity, by looking at the maximum/minimum diameter; iv) mean diameter. To understand the association between the main modes and the shape variance, these parameters were compared, for each level of osteotomy, between the two extreme geometries of the main modes of variation.

Results from PCA pointed out that the first three PCs explained more than the 87% of the total variance, for each level of simulated osteotomy. By analysing the extreme geometries for a distal osteotomy (e.g. 80% of the length of the canal), the first PC was associated to a combination of ROC (var%=41%), conicity (var%=28%) and ellipticity (var%=7%). PC2 was still associated with the ROC (var%=16%), while PC3 turned out to be associated with the diameter (var%=38%).

Through the SSM presented in this study, a quantitatively evaluation of the deformation of the intramedullary canal has been made possible. By analysing the extreme geometries obtained from the first three modes of variance, it is clear that the first three PCs accounted for the variations in terms of curvature, conicity, ellipticity and diameter of the femoral canal with a different weight, depending on the level of osteotomy. Through this work, it was also possible to parametrize these variations according to the level of excision. The results given for the segment corresponding to the 80% of the length of the canal showed that, at that specified level, the ROC, conicity and ellipticity were the anatomical parameters with the highest range of variability, followed by the variation in terms of diameter. Therefore, the analysis carried out can provide information about the relevance of these parameters depending on the level of osteotomy suffered by the amputee. In this way, optimal strategies for the design and/or customization of osteo-integrated stems can be offered depending on the patient's residual limb.

Summary. The required torque leading to an abrasion of the passive layer in the stem-head interface positively correlates to the assembly force. In order to limit the risk of fretting and corrosion a strong hammer blow seems to be necessary. Introduction. Modular hip prostheses are commonly used in orthopaedic surgery and offer a taper connection between stem and ball head. Taper connections are exposed to high bending loads and bear the risk of fretting and corrosion, as observed in clinical applications. This is particularly a problem for large diameter metal bearings as the negative effects may be enhanced due to the higher moments within the taper connection. Currently, it is not known how much torque is required to initiate a removal of the passive layer, which might lead to corrosion over a longer period and limits the lifetime of prostheses. Therefore, the purpose of this study was to identify the amount of torque required to start an abrasion of the passive layer within the interface dependent on the assembly force and the axial load. Materials and Methods. Titanium hip stems (Furlong H-AC, JRI, UK) and cobalt-chromium heads (⊘ 28mm, size L, JRI, UK) were assembled using a drop rig with peak forces of 4.5 kN (F. P,1. , n = 4) or 6.0 kN (F. P,2. , n = 4). The prostheses were inverted and then mounted with the head rigidly fixed to the base of a materials testing machine using a non-conducting (nylon) jig while submerged in Ringer's solution. The stems were attached to the machine actuator via non-conductive plates. An axial load (F. A,1. = 1 kN, F. A,2. = 3 kN, n = 4 each) was applied to the stems along the taper axis. After a period of equilibration a torque, increasing from 0 up to 15Nm, was manually applied. The galvanic potential at the taper interface was continuously recorded using a titanium electrode. The torque required to cause a drop in the potential of 5% was identified. For statistical analyses non-parametric tests were performed (α = 0.05). Results. Four different phases of the potential could be clearly differentiated during testing: equilibrium, removal of the passive layer leading to a drop of the potential, repassivation and then a second equilibrium. Prostheses assembled with a force of 6 kN required a significantly higher torque to start a removal of the passive layer compared to those with 4.5 kN (7.2 ± 0.5 Nm vs. 3.9 ± 1.0 Nm for F. A,1. , p = 0.029). In contrast, no influence of the axial load on the fretting behaviour of the prostheses could be found (8.0 ± 1.6 Nm for F. P,2. , p = 0.486). Discussion. Changes in the galvanic potential were observed at low torque levels for a small head diameter. With increasing head diameter the tangential force leading to a removal of the passive layer in the stem-head interface decrease resulting in a higher risk for corrosion. Component assembly with a high force reduces the risk of fretting and corrosion in the taper interface; however, it is feasible that the determined torque levels can still be reached, particularly in situations of large weight and high activity of the patient or malpositioning of the prosthesis in the body

Dual mobility hip arthroplasty utilizes a freely rotating polyethylene liner to protect against dislocation. As liner motion has not been confirmed in vivo, we investigated the liner kinematics in vivo using dynamic radiostereometry.

16 patients with Anatomical Dual Mobility acetabular components were included. Markers were implanted in the liners using a drill guide. Static RSA recordings and patient reported outcome measures were obtained at post-op and 1-year follow-up. Dynamic RSA recordings were obtained at 1-year follow-up during a passive hip movement: abduction/external rotation, adduction/internal rotation (modified FABER-FADIR), to end-range and at 45° hip flexion. Liner- and neck movements were described as anteversion, inclination and rotation.

Liner movement during modified FABER-FADIR was detected in 12 of 16 patients. Median (range) absolute liner movements were: anteversion 10° (5–20), inclination 6° (2–12), and rotation 11° (5–48) relative to the cup. Median absolute changes in the resulting liner/neck angle (small articulation) was 28° (12–46) and liner/cup angle (larger articulation) was 6° (4–21). Static RSA showed changes in median (range) liner anteversion from 7° (-12–23) postoperatively to 10° (-3–16) at 1-year follow-up and inclination from 42 (35–66) postoperatively to 59 (46–80) at 1-year follow-up. Liner/neck contact was associated with high initial liner anteversion (p=0.01).

The polyethylene liner moves over time. One year after surgery the liner can move with or without liner/neck contact. The majority of movement is in the smaller articulation between head and liner.

Abstract

Background

Aseptic loosening of prostheses is the most common cause for failure in total joint arthroplasty. Particulate wear debris induces a non-stop inflammatory-like response resulting in the formation of a layer of fibrous periprosthetic tissue at the bone/implant interface. The current treatment is an invasive revision joint replacement surgery. However, this procedure has a high morbidity rate, therefore, a less invasive alternative is necessary. One approach could be to re-establish osseointegration of the joint prosthesis by inducing osteoblast differentiation in the periprosthetic tissue. Therefore, the aim of this study was to investigate the capacity of periprosthetic tissue cells to differentiate into the osteoblast lineage.

Introduction

There is much current debate concerning wear and corrosion at the taper junctions of large head total hip replacements, particularly metal-on-metal hips. Is such damage a modern concern or has it always occurred in total hip replacement but not previously noted. To investigate this five explanted V40 Exeter femoral stems (Stryker Howmedica) were obtained following revision surgery at a single centre. In all cases, the 24–26 mm femoral heads were still attached.

Introduction

Total hip prostheses which use a ceramic head within a metal liner are a relatively recent introduction. As such, survivorship rates from independent centres alongside explant analysis are rare. The early experience with this novel ceramic-on-metal (CoM) bearing couple is reported.

Patient function is poorly characterised following revision TKA. Modern semi-constrained implants are suggested to offer high levels of function, however, data is lacking to justify this claim.

52 consecutive aseptic revision TKA procedures performed at a single centre were prospectively evaluated; all were revision of a primary implant to a Triathlon total stabiliser prosthesis. Patients were assessed pre-operatively and at 6, 26, 52 and 104 weeks post-op. Outcome assessments were the Oxford Knee Score (OKS), range of motion, pain rating scale and timed functional assessment battery. Analysis was by repeated measures ANOVA with post-hoc Tukey HSD 95% simultaneous confidence intervals as pairwise comparison. Secondary analysis compared the results of this revision cohort to previously reported primary TKA data, performed by the same surgeons, with identical outcome assessments at equivalent time points.

Mean age was 73.23 (SD 10.41) years, 57% were male. Mean time since index surgery was 9.03 (SD 5.6) years. 3 patients were lost to follow-up. All outcome parameters improved significantly over time (p <0.001). Post-hoc analysis demonstrated that all outcomes changed between pre-op, 6 week and 26 weeks post-op assessments.

No difference was seen between primary and revision cohorts in OKS (p = 0.2) or pain scores (p=0.19). Range of motion and functional performance was different between groups over the 2 year period (p=0.03), however this was due to differing pre-operative scores, post-hoc analysis showed no difference between groups at any post-operative time point.

Patients undergoing aseptic revision TKA with semi-constrained implants made substantial improvements in OKS, pain scores, knee flexion, and timed functional performance, with the outcomes achieved comparable to those of primary TKA. High levels of function can be achieved following revision knee arthroplasty, which may be important considering the changing need for, and demographics of, revision surgery.

Finger arthroplasty lacks the success seen with hip and knee joint replacements. The Van Straten Leuwen Poeschmann Metal (LPM) prosthesis was intended for the proximal interphalangeal (PIP) joints. However revision rates of 30% after 19 months were reported alongside massive osteolysis. Three failed LPM titanium niobium (TiNb) coated cobalt chrome (CoCr) components were obtained- two distal and one proximal.

All three components were analysed using an environmental scanning electron microscope (ESEM). This gave the chemical composition of the surface to determine if the TiNb surface coating was still intact. The distal components were analysed using a ZYGO non-contact profilometer (1nm resolution) with the proximal component unable to be analysed due to its shape. ZYGO analysis gave the roughness average (Ra) of the surface and determined the presence of scratches, pitting and other damage.

Images obtained from both the ZYGO and the ESEM indicated that the surfaces of all components were heavily worn. On the articulating surfaces of both distal components unidirectional scratching was dominant, while the non-articulating surface showed multidirectional scratching. The presence of unidirectional scratching suggested two-body wear, whilst the multidirectional scratching on the non-articulating surface of the distal component suggested that trapped debris may have caused three-body wear.

The ESEM chemical analysis showed that in some regions on the distal component the TiNb coating had been removed completely and in other areas it had been scratched or penetrated. On the proximal component the TiNb coating had been almost completely removed from the articulating surfaces and was only present in small amounts on the non-articulating surfaces. There was little evidence of bone attachment to the titanium coating which was intended to help provide fixation.

ESEM images showed the coating had been removed in some sections where there was minimal scratching, suggesting this scratching did not impact significantly in the coating removal. Therefore here the main cause of coating removal may have been corrosion, although scratching may have also have played a part.

The osteolysis reported clinically may have been linked to the wear debris from the failed coating.

Introduction

Ten explanted pyrolytic carbon components of a number of finger prostheses were obtained at revision surgery for wear analysis. Implants were removed for either dislocation or failure of fixation. Hypothesis Failure of the components was due to wear from the articulating surfaces, as occurs in many hip and knee prostheses.

Wear debris induced osteolysis is a recognized complication in conventional metal-on-polyethylene hip arthroplasty. One method of achieving wear reduction is through the use of metal-on-metal articulations. One of the latest manifestations of this biomaterial combination is in designs of hip resurfacing which are aimed at younger, more active patients. But, do these metal-on-metal hip resurfacings show low wear when implanted into patients?

Using a Mitutoyo Legex 322 co-ordinate measuring machine (scanning accuracy less than 1 micron) and a bespoke computer program, volumetric wear measurements for retrieved Articular Surface Replacements (ASR, DePuy) metal-on-metal hip resurfacings were undertaken. Measurements were validated against gravimetric calculations for volumetric wear using a sample femoral head that was artificially worn in vitro. At 5mm3, 10mm3, and 15mm3 of material removal, the method was shown to be accurate to within 0.5mm3.

Thirty-two femoral heads and twenty-two acetabular cups were measured. Acetabular cups exhibited mean volumetric wear of 29.00mm3 (range 1.35 - 109.72mm3) and a wear rate of 11.02mm3/year (range 0.30 - 63.59mm3/year). Femoral heads exhibited mean wear of 22.41mm3 (range 0.72 - 134.22mm3) and a wear rate of 8.72mm3/year (range 0.21 - 31.91mm3/year). In the 22 cases where both head and cup from the same prosthesis were available, mean total wear rates of 21.66mm3/year (range 0.51 - 95.50mm3/year) were observed.

Revision was necessitated by one of five effects; early femoral neck fracture (4 heads), avascular necrosis (AVN) (2 heads, 1 cup), infection (1 head, 1 cup), adverse reaction to metal debris (ARMD) (19 heads, 18 cups) or ARMD fracture (6 heads, 2 cups). Mean paired wear rates for the AVN and infection retrievals were 0.51mm3/year and 3.98mm3/year respectively. In vitro tests typically offer wear rates for metal-on-metal devices in the region of 2-4mm3.

Mean paired wear rates for ARMD and ARMD fracture were 17.64mm3/year and 68.5mm3/year respectively, significantly greater than those expected from in vitro tests. In the 4 cases of early fracture, only the heads were revised so a combined wear rate calculation was not possible. The heads exhibited mean wear rate of 8.26mm3/year. These high wear rates are of concern.

We retrieved 159 femoral heads at revision surgery to determine changes in surface configuration. Macroscopic wear of the head was observed in three bipolar hip prostheses as a result of three-body wear. There was a considerable change in surface roughness in the internal articulation of bipolar hip prostheses. Roughness in alumina heads was almost the same as that in new cobalt-chromium heads. The annual linear wear rate of polyethylene cups with alumina heads was less than that of cups with cobalt-chromium alloy heads. Polyethylene wear was increased in the prostheses which had increased roughness of the head.

Summary

Micromotions between stem and neck adapter depend on prosthesis design and material coupling. Based on the results of this study, the amount of micromotion seems to reflect the risk of fretting-induced fatigue in vivo.

Summary Statement

Femorotibial constraint is a key property of a total knee arthroplasty (TKA) prosthesis and should reflect the intended function of the device. With a validated simulation methodology, this study evaluated the constraint of two TKA prostheses designed for different intentions.

Summary

There is little knowledge in surgeons about the guidelines for prophylactic antibiotics in patients with prosthetic joints when undergoing a dental procedure. This study confirms this and there is need for robust and universal guidelines given the disastrous nature of prosthetic infection.

Summary

In this study we validate that weight-bearing images are needed for accurate polyethylene liner wear measurement in total knee prostheses by measuring the difference in minimum joint space width between weight-bearing and non-weight-bearing RSA views.

Summary

Particulate wear debris with different chemical composition induced similar periprosthetic tissue reactions in patients with loosened uncemented and cemented titanium hip implants, which suggests that osteolysis can develop independent of particle composition.