Introduction

An understanding of anatomic variability can help guide the surgeon on intervention strategies. Well-functioning thumb metacarpophalangeal joints (MCPJ) are essential for carrying out typical daily activities. However, current options for arthroplasty are limited. This is further hindered by the lack of a precise understanding of the geometric variation present in the population. In this paper, we offer new insight into the major modes of geometric variation in the thumb MCP using Statistical Shape Modelling.

INTRODUCTION

Hip resurfacing offers a more bone conserving solution than total hip replacement (THR) but currently has limited clinical indications related to some poor design concepts and metal ion related issues. Other materials are currently being investigated based on their successful clinical history in THR such as Zirconia Toughened Alumina (ZTA, Biolox Delta, CeramTec, Germany) which has shown low wear rates and good biocompatibility but has previously only been used as a bearing surface in THR. A newly developed direct cementless fixation all-ceramic (ZTA) resurfacing cup offers a new solution for resurfacing however ZTA has a Young's modulus approximately 1.6 times greater than CoCr - such may affect the acetabular bone remodelling. This modelling study investigates whether increased stress shielding may occur when compared to a CoCr resurfacing implant with successful known clinical survivorship.

Polymer foams have been extensively used in the testing and development of orthopaedic devices and computational models. Often these foams are used in preference to cadaver and animal models due to being relatively inexpensive and their consistent material properties. Successful validation of such models requires accurate material/mechanical data. The assumed range of compressive moduli, provided in the sawbones technical sheet, is 16 MPa to 1.15 GPa depending on the density of foam. In this investigation, we apply two non-contact measurement techniques (digital volume correlation (DVC) and optical surface extensometry/point-tracking) to assess the validity of these reported values. It is thought that such non-contact methods remove mechanical extensometer errors (slippage, misalignment) and are less sensitive to test-machine end-artifacts (friction, non-uniform loading, platen flexibility). This is because measurement is taken directly from the sample, and hence material property assessment should be more accurate. Use of DVC is advantageous as full field strain measurement is possible, however test time and cost is significantly higher than extensometry. Hence, the study also sought to assess the viability of optical extensometry for characterising porous materials.

Testing was conducted on five 20 mm cubic samples of 0.32g/cc (20 pcf) solid rigid polyurethane foam (SAWBONESTM). The strain behaviour was characterised by incremental loading via an in situ loading rig. Loading was performed in 0.1 mm increments for 8 load steps with scans between loading steps. Full field strain measurement was performed on one sample by micro focus tomography (muvis centre, Southampton) and subsequent DVC (DaVis, Lavision). Average strains in each direction were then calculated to enable modulus and Poisson's ratio calculation. These results were subsequently corroborated by use of optical point-tracking (MatchID). To account for heterogeneities, axial strain measurements were averaged from six points on the front and rear surfaces (fig.2). In each test compressive displacement was applied to 900N (∼2MPa) to remain within the linear elastic region.

Significant variability of individual strain measurements were observed from point couples on the same sample, indicating non-uniform loading did occur in all samples. However, by averaging across multiple points, linear loading profiles were ascertained (fig.2). For all non-contact methods the calculated elastic moduli were found to range between 331–428 MPa whilst the approximated modulus based on cross head displacement was ∼210 MPa, similar to the manufacturer's quoted value (220MPa). The point-tracking gave a significantly higher modulus (p = 0.047) than the DVC results as only surface measurements were made. It is thought that a correction factor may be ascertained from the finite element method to correct this. Both the DVC and point-tracking results (p = 0.001) indicated a substantially higher compressive modulus than the manufacturer provided properties.

This study demonstrates that methods of measuring displacement data on cellular foams must be carefully considered, as artefacts can lead to errors of up to 70% compared to optical and x-ray based techniques.

Introduction

Periprosthetic bone remodelling after Total Knee Arthroplasty (TKA) may be attributed to local changes in the mechanical strain field of the bone as a result of the stiffness mismatch between high modulus metallic implant materials and the supporting bone. This can lead to significant loss of periprosthetic bone density, which may promote implant loosening, and complicate revision surgery. A novel polyetheretherketone (PEEK) implant with a modulus similar to bone has the potential to reduce stress shielding whilst eliminating metal ion release. Numerical modelling can estimate the remodelling stimulus but rigorous validation is required for use as a predictive tool. In this study, a finite element (FE) model investigating the local biomechanical changes with different TKA materials was verified experimentally using Digital Image Correlation (DIC). DIC is increasingly used in biomechanics for strain measurement on complex, heterogeneous anisotropic material structures.

Introduction

Implant-cement debonding at the knee has been reported previously [1]. The strength of the mechanical interlock of bone cement on to an implant surface can be associated with both bone cement and implant related factors. In addition to implant surface profile, sub-optimal mixing temperatures and waiting times prior to cement application may weaken the strength of the interlock.

Introduction

Fatigue and wear at the head/stem modular junction of large diameter total hip replacements can be exacerbated as a result of the increase in frictional torque. In vivo, a “toggling,” anterior-posterior (A-P) movement of the head taper on the trunnion may facilitate corrosion in the presence of physiological fluids, leading to increased metal ion release. Clinically, metal ion release has been linked to the formation of pseudo tumours and tissue necrosis [1].

Introduction:

Novel biomaterials may offer alternatives to metal arthroplasty bearings. To employ these materials in thin, bone conserving implants would require direct fixation to bone, using Titanium/HA coatings. Standard tests are used to evaluate the adhesion strength of coatings to metal substrates [1], versus FDA pass criteria [2]. In tensile adhesion testing, a disc is coated and uniform, uniaxial tension is exerted upon the coating-substrate interface; the strength is calculated from the failure load and surface area. Rapid failure occurs when the peak interface stress exceeds the adhesion strength, as local failure will propagate into an increasing tensile stress field.

Ceramics and reinforced polymers (e.g. carbon-fibre-reinforced PEEK), have considerably different stiffness (E) and Poisson's Ratio (ν) from the coating and implant metals. We hypothesised that this substrate-coating stiffness mismatch would produce stress concentrations at the interface edge, well in excess of the uniform stress experienced with coatings on similar stiffness metals.

Representative pre-clinical analysis is essential to ensure that novel prosthesis concepts offer an improvement over the state-of-the-art. Proposed designs must, fundamentally, be assessed against cyclic loads representing common daily activities [Bergmann 2001] to ensure that they will withstand conceivable in-vivo loading conditions. Fatigue assessment involves:

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cyclic mechanical testing, representing worst-case peak loads encountered in-vivo, typically for 10 million cycles, or

Cyclic stresses from gait loading are super-imposed upon residual assembly stresses. In thick walled devices, the residual component is small in comparison to the cyclic component, but in thin section, bone preserving devices, residual assembly stresses may be a multiple of the cyclic stresses, so a different approach to fatigue assessment is required.

Modular devices provide intraoperative flexibility with minimal inventories. Components are assembled in surgery with taper interfaces, but resulting residual stresses are variable due to differing assembly forces and potential misalignment or interface contamination. Incorrect assembly can lead to incomplete seating and dissociation [Langdown 2007], or fracture due to excessive press-fit stress or point loading [Hamilton 2010]. Pre-assembly in clean conditions, with reproducible force and alignment, gives close control of assembly stresses. Clinical results indicate that this is only a concern with thick sectioned devices in a small percentage of cases [Hamilton 2010], but it may be critical for thin walled devices.

A pre-clinical analysis method is proposed for this new scenario, with a case study example: a thin modular cup featuring a ceramic bearing insert and a Ti-6Al-4V shell (Fig. 1). The design was assessed using FE predictions, and manufacturing variability from tolerances, surface finish effects and residual stresses was assessed, in addition to loading variability, to ensure physical testing is performed at worst case:

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assembly loads were applied, predicting assembly residual stress, verified by strain gauging, and a range of service loads were superimposed.

The predicted worst-case stress conditions were analysed against three ‘constant life’ limits [Gerber, 1874, Goodman 1899, Soderberg 1930], a common aerospace approach, giving predicted safety factors. Finally, equivalent fatigue tests were conducted on ten prototype implants.

Taking a worst-case size (thinnest-walled 48 mm inner/58 mm outer), under assembly loading the peak tensile stress in the titanium shell was 274 MPa (Fig. 2). With 5kN superimposed jogging loading, at an extreme 75° inclination, 29 MPa additional tensile stress was predicted. This gave mean fatigue stress of 288.5 MPa and stress amplitude of 14.5 MPa (R=0.9). Against the most conservative infinite life limit (Soderberg), the predicted safety factor was 2.40 for machined material, and 2.03 for forged material, or if a stress-concentrating surface scratch occurs during manufacturing or implantation (Fig. 3). All cups survived 10,000,000 fatigue cycles.

This study employed computational modelling and physical testing to verify the strength of a joint prosthesis concept, under worst case static and fatigue loading conditions. The analysis technique represents an improvement in the state of the art where testing standards refer to conventional prostheses; similar methods could be applied to a wide range of novel prosthesis designs.

Developmental dysplasia of the hip is a condition in which the acetabulum provides insufficient coverage of the femoral head in the hip joint. This configuration gives poor biomechanical load distribution, with increased stress at the superior aspect of the joint surfaces, and can often lead to degenerative arthritis. Morphologically, the poor coverage may be due to an acetabulum that is too shallow or oriented in valgus.

The dysplastic deformity can be treated surgically with a group of similar procedures, often labeled periacetabular osteotomies or rotational acetabular osteotomies. Each involves separating the acetabulum from the pelvis and fixating the fragment back to the pelvis in an orientation with increased coverage of the femoral head. This redistributes the biomechanical loads relative to acetabulum.

Bone remodeling at the level of trabeculae is an accepted concept under research; however, it is unclear whether the hip undergoes gross morphology changes in response to changes in biomechanical loading. An understanding of the degree to which this remodeling occurs (if at all) may have an impact on surgical planning.

In this retrospective study, computed tomography (CT) scans of 13 patients (2 male, 11 female, 40 ± 9 years of age) undergoing unilateral periacetabular osteotomies were examined; scans were taken both pre-operatively and at least a year post-operatively with an in-plane resolution of 0.55 mm and a slice thickness of 1.25 mm. Scans were segmented to produce triangulated meshes for the proximal femurs and the pelvis. These scans were manually processed to isolate the articular portions of the femoral heads and acetabulums, respectively; the fovea, acetabular fossa, any osteophytes and any segmentation artifacts were excluded.

Post-operative meshes were registered to their pre-operative counterparts for both the femoral head and the acetabulum, for both the operative and non-operative hips, using the iterative closest point (ICP) algorithm to 20 iterations. To account for differences in defining the edges of the articular surfaces in the manual isolation, metrics were only calculated using points that were within 0.3 mm of a normal from the opposing mesh. With the resulting matched data, nearest neighbour distances were calculated to form the remodeling metrics. Select spurious datapoints were removed manually.

For the operative femoral heads, the registered post-operative points were 0.24±0.53 mm outside of the pre-operative points. The maximum deviation was on average 1.94 mm with worst-case of 2.99 mm; the minimum deviation was −0.62 mm with worst-case of −2.06 mm. Positive numbers indicate the post-operative points are ‘outside’ of the pre-operative points – that is, farther from the head centre. The non-operative femoral heads have similar deviation values, 0.21±0.46 mm outside, with maximum and minimum deviation averaging to 1.24 mm and −0.74 mm respectively, with worst cases of 2.99mm and −1.80mm.

For the operative acetabulums, the post-operative deviations were −0.08±0.43mm. The maximum and minimum deviations averaged to 0.62mm and −0.82mm, with worst cases of 2.14mm and −1.51mm across the set. Again, the non-operative acetabulums were very similar; post-operative deviations were −0.02±0.43mm, maximum and minimum deviations averaged to 1.24mm and −0.65mm, with worst cases of 1.97mm and −2.00mm.

These quantitative measurements were reflected in manual examination of the meshes; generally speaking, there were small deviations with no overarching patterns across the anatomy.

All metrics were very similar across the same anatomy (that is, femoral head or acetabulum) regardless of whether the hip operative or non-operative. Femurs tended to ‘grow’ slightly post-operatively, but by less than a half voxel in size. Given that the CT voxels are large compared to the measured deviations, it is possible the results may be sensitive to the manual segmentations used as source data.

Manual examination of the deviations indicated a few potential trends. Seven operative and eleven non-operative acetabulums had a small patch of positive deviation (1mm to 1.5mm) in the anterosuperior aspect. This can be seen in the plot as the yellow-red area near the top right of the leftmost rendering. Other high-deviation areas included the superior aspect of the acetabulum (both positive and negative) and the superior aspect of the femoral head (generally positive).

The edges of the mesh were often a source of high deviation. This is likely an artifact of over-inclusion the manual isolation of the articular surfaces, as joint surfaces become non-articular as they move away from the joint interface.

Overall, the superior and anterosuperior aspects of the acetabulum and the superior aspect of the femoral head showed some indication of systemic changes; further study may clarify whether these data represent consistent anatomical changes. However, as the magnitude of the deviations between pre- and post-operative scans are on or below the order of the CT voxel size, we conclude that (in the absence of other strongly compelling evidence) periacetabular osteotomies for adults should be planned without the expectation of gross remodeling of the articular surfaces.

INTRODUCTION

Resurfacing prostheses are implanted by impaction onto the prepared femoral head. Ceramic resurfacings can be proposed as an alternative to metal implants, combining bone conservation with mitigation of sensitivity reaction risks. With low wall-thickness required for bone conservation, their strength must be verified. This study aimed to assess a ceramic resurfacing prosthesis' strength under surgical loads using a computational model, tuned and verified with physical tests.