Evaluating the use of a novel low-cost measurement insole to characterise plantar foot strain during gait loading regimes

Introduction: Under plantar loading regimes, it is accepted that both pressure and shear strain biomechanically contribute to formation and deterioration of diabetic foot ulceration (DFU). Plantar foot strain characteristics in the at-risk diabetic foot are little researched due to lack of measurement devices. Plantar pressure comparatively, is widely quantified and used in the characterisation of diabetic foot ulceration risk, with a range of clinically implemented pressure measurement devices on the market. With the development of novel strain quantification methods in its infancy, feasibility testing and validation of these measurement devices for use is required. Initial studies centre on normal walking speed, reflecting common activities of daily living, but evaluating response to differing gait loading regimes is needed to support the use of such technologies for potential clinical translation. This study evaluates the effects of speed and inclination on stance time, strain location and strain response using a low-cost novel strain measurement insole.Methods: The STrain Analysis and Mapping of the Plantar Aspect (STAMPS) insole has been developed, and feasibility tested under self-selected normal walking speeds to characterise plantar foot strain, with testing beyond this limited regime required. A treadmill was implemented to standardise speed and inclination for a range of daily plantar loading conditions. A small cohort, comprising of five non-diabetic participants, were examined at slow (0.75 m/s), normal (1.25 m/s) and brisk (2 m/s) walking speeds and normal speed at inclination (10% gradient).Results: Plantar strain active regions were seen to increase with increasing speed across all participants. With inclination, it was seen that strain active regions reduce in the hindfoot and show a tendency to forefoot with discretionary changes to strain seen. Stance time decreases with increasing speed, as expected, with reduced stance time with inclination.Discussion: Comparison of the strain response and stance time should be considered when evaluating foot biomechanics in diabetic populations to assess strain time interval effects. This study supports the evaluation of the STAMPS insole to successfully track strain changes under differing plantar loading conditions and warrants further investigation of healthy and diabetic cohorts to assess the implications for use as a risk assessment tool for DFU

Clinically useful finite element models of the natural ankle – a review

Background:Biomechanical simulation of the foot and ankle complex is a growing research area but compared to simulation of joints such as hip and knee, it has been under investigated and lacks consistency in research methodology. The methodology is variable, data is heterogenous and there are no clear output criteria. Therefore, it is very difficult to correlate clinically and draw meaningful inferences.Methods:The focus of this review is finite element simulation of the native ankle joint and we will explore: the different research questions asked, the model designs used, ways the model rigour has been ensured, the different output parameters of interest and the clinical impact and relevance of these studies.Findings:The 72 published studies explored in this review demonstrate wide variability in approach. Many studies demonstrated a preference for simplicity when representing different tissues, with the majority using linear isotropic material properties to represent the bone, cartilage and ligaments; this allows the models to be complex in another way such as to include more bones or complex loading. Most studies were validated against experimental or in vivo data, but a large proportion (40%) of studies were not validated at all, which is an area of concern.Interpretation:Finite element simulation of the ankle shows promise as a clinical tool for improving outcomes. Standardisation of model creation and standardisation of reporting would increase trust, and enable independent validation, through which successful clinical application of the research could be realised

The relationship between subchondral bone cysts and cartilage health in the Tibiotalar joint: A finite element analysis

Background: Subchondral bone cysts are a common presentation in ankle haemarthropathy. The relationship with ankle joint health has however not previously been investigated. The aim of this study was to assess the influence of subchondral bone cysts of differing shapes, volumes and depths on joint health. Methods: Chronologically sequential Magnetic Resonance imaging scans of four hemophilic ankles with subchondral bone cysts present (N = 18) were used to build patient specific finite element models under two cystic conditions to assess their influence on cartilage contact pressures. Variables such as location, volume and depth were considered individually, to investigate whether certain cystic conditions may be more detrimental to cartilage health. Findings: Significant quantifiable contact redistribution was seen in the presence of subchondral bone cysts and this redistribution reflected the shape and size of the cysts, however, with the presence of cysts in both bones in 10 of the 18 cases a direct relationship to volume could not be correlated. Interpretation: This work demonstrated a redistribution of contact pressures in the presence of subchondral bone cysts. This alteration to loading history could be linked to cartilage degeneration due to the biological response to abnormal loading

Mechanical characteristics of diabetic and non-diabetic plantar skin

Diabetic foot ulceration is linked to high amputation and mortality rates, with the substantial associated annual spend on the at-risk diabetic foot reflecting the intensive time and labour involved in treatment. Assessing plantar interactions and developing improved understanding of the formation pathways of diabetic ulceration is important to orthotic interventions and patient outcomes. Plantar skin surrogates which emulate the mechanical and tribological characteristics can help improve physical models of ulceration, reduce reliance on cadaveric use and inform more complex computational modelling approaches. The information available from existing studies to characterise plantar skin is limited, typically featuring ex-vivo representations of skin and subcutaneous tissue combined and given focus to shear studies with time dependency. The aim of this study is to improve understanding of plantar tissue mechanics by assessing the mechanical characteristics of plantar skin in two groups; (1) non-diabetic and (2) diabetic donors without the subcutaneous tissue attachment of previous work in this field. Digital image correlation was used to assess inherent skin pre-tension of the plantar rearfoot prior to dissection. Young’s modulus, storage and loss moduli were tested for using tensile stress–strain failure analysis and tensile and compressive dynamic mechanical analysis, which was conducted on excised plantar rearfoot donor specimens for both disease state cohorts at frequencies reflecting those achieved in activities of daily living. Plantar skin thickness for donor specimens were comparable to values obtained using ultrasound acquired in vivo values. Median tensile storage and loss moduli, along with Young’s modulus, was higher in the diabetic cohort. With a mean Young’s modulus of 0.83 ± 0.49 MPa and 1.33 ± 0.43 MPa for non-diabetic and diabetic specimens respectively. Compressive studies showed consistency between cohorts for median storage and loss moduli. The outcomes from this study show mechanical characteristics of plantar skin without the involvement of subcuteanous tissues under reflective daily achieved loading regimes, showing differences in the non-diabetic and diabetic specimens trialled to support improved understanding of plantar tissue response under tribological interactions

Morphological variation of the hemophilic talus

Flattening of the trochlear tali is clinically observed as structural and functional changes advance in patients with hemarthropathy of the ankle. However, the degree of this flattening has not yet been quantified, and distribution of the morphological changes across the talus not yet defined. Chronologically sequential MR images of both a hemophilic patient group (N = 5) and a single scan from a nondiseased, sex-matched, control group (N = 11) were used to take four measurements of the trochlear talus morphology at three locations (medial, central and lateral) along the sagittal plane. Three ratios of interest were defined from these to assess whether the talar dome flattens with disease. The control group MRI measurements were validated against literature data obtained from CT scans or planar X-Rays. The influence of disease on talar morphology was assessed by direct comparison of the hemophilic cases with the control group. The values for all three ratios, in all locations, differed between the control and the hemophilic group. Flattening was indicated in the hemophilic group in the medial and lateral talus, but differences in the central talus were not statistically significant. This work demonstrates that morphological assessment of the talus from MR images is similar to that from CT scans or planar X-Rays. Talar flattening does occur with hemarthropathy, especially at the medial and lateral edges of the joint surface. General flattening of the trochlear talus was confirmed in this small patient sample, however the degree and rate of change is unique to each ankle

Knee joint neuromuscular activation performance during muscle damage and superimposed fatigue

This study examined the concurrent effects of exercise-induced muscle damage and superimposed acute fatigue on the neuromuscular activation performance of the knee flexors of nine males (age: 26.7 ± 6.1yrs; height 1.81 ± 0.05m; body mass 81.2 ± 11.7kg [mean ± SD]). Measures were obtained during three experimental conditions: (i) FAT-EEVID, involving acute fatiguing exercise performed on each assessment occasion plus a single episode of eccentric exercise performed on the first occasion and after the fatigue trial; (ii) FAT, involving the fatiguing exercise only and; (iii) CON consisting of no exercise. Assessments were performed prior to (pre) and at lh, 24h, 48h, 72h, and 168h relative to the eccentric exercise. Repeated-measures ANOVAs showed that muscle damage within the FAT-EEVID condition elicited reductions of up to 38%, 24%) and 65%> in volitional peak force, electromechanical delay and rate of force development compared to baseline and controls, respectively (F[io, 80] = 2.3 to 4.6; p to 30.7%>) following acute fatigue (Fp; i6] = 4.3 to 9.1; p ; Fp, iq = 3.9; p <0.05). The safeguarding of evoked muscle activation capability despite compromised volitional performance might reveal aspects of capabilities for emergency and protective responses during episodes of fatigue and antecedent muscle damaging exercise

Incorporating pathological gait into patient-specific finite element models of the haemophilic ankle

Haemarthrosis is an inherent clinical feature of haemophilia, a disease characterised by an absence or reduction in clotting proteins. Patients with severe haemophilia experience joint bleeding leading to blood-induced ankle arthropathy (haemarthropathy). Altered biomechanics of the ankle have been reported in people with haemophilia; however, the consequence of this on joint health is little understood. The aim of this study was to assess the changes in joint contact due to haemophilia disease-specific gait features using patient-specific modelling, to better understand the link between biomechanics and joint outcomes. Four, image-based, finite element models of haemophilic ankles were simulated through consecutive events in the stance phase of gait, using both patient-specific and healthy control group (n = 36) biomechanical inputs. One healthy control FE model was simulated through the healthy control stance phase of the gait cycle for a point of comparison. The method developed allowed cartilage contact mechanics to be assessed throughout the loading phase of the gait cycle. This showed areas of increased contact pressure in the medial and lateral regions of the talar dome, which may be linked to collapse in these regions. This method may allow the relationship between structure and function in the tibiotalar joint to be better understood

A COMPARISON OF ELECTROMECHANICAL VERSUS PNEUMATIC-CONTROLLED KNEE SIMULATORS FOR THE WEAR PERFORMANCE OF A TOTAL ANKLE ARTHROPLASTY

Objectives Implant loosening remains a common cause of total ankle replacement (TAR) revision, and has been associated with wear-mediated osteolysis. Limited pre-clinical studies for TARs have been reported and the variety of experiment settings make it difficult to compare wear rates. Factors such as simulator control mechanism; whether pneumatic or electromechanical, may influence the integrity of the simulator outputs with respect to input profiles. This study compares the wear of a TAR, tested in electromechanical and pneumatic experimental simulators under identical input conditions. Methods Twelve medium BOX® (MatOrtho Ltd) TARs (n=6 for each simulator) were tested in an electromechanical and pneumatic knee simulator (Simulation Solutions, UK) for 3 million cycles (Mc). Standard ‘Leeds’ displacement-controlled inputs were used. Kinematic performance was investigated by comparing the output profiles against the maximum demanded input values. The lubricant used was 25% new-born calf serum and wear was determined gravimetrically. Results There was no significant difference (P=0.66) in wear rate between simulators (electromechanical = 15.96 ± 6.37mm3/Mc; pneumatic = 14.51 ± 5.27mm3/Mc). The electromechanical simulator (3157.06 ± 1.52N) achieved the maximum load (3150N), but the pneumatic simulator was unable to attain the demand (2542.34 ± 86.52N). Maximum AP displacement from the electromechanical simulator was 3.27 ± 0.07mm (3.1mm input), compared to 3.62 ± 0.95mm from the pneumatic simulator. Internal/external rotation angle was 7.97° ± 0.00 (8° input) and 7.24° ± 0.12 from the electromechanical and pneumatic simulators respectively. Both simulators achieved the demanded flexion angle (±15°). Conclusions The outputs from the electromechanical simulator followed the input profiles more closely than the pneumatic simulator. Despite these differences, there was no significant influence on wear rate. The variation in kinematics between simulators was not sufficient to significantly change the tribological conditions of the TAR. The authors recommend the use of electromechanical simulators for future studies where more demanding and adverse conditions may be applied

Characterisation of native and decellularised porcine tendon under tension and compression : a closer look at glycosaminoglycan contribution to tendon mechanics

Decellularised porcine superflexor tendon (pSFT) has been characterised as a suitable scaffold for anterior cruciate ligament replacement, with dimensions similar to hamstring tendon autograft. However, decellularisation of tissues may reduce or damage extracellular matrix components, leading to undesirable biomechanical changes at a whole tissue scale. Although the role of collagen in tendons is well established, the mechanical contribution of glycosaminoglycans (GAGs) is less evident and could be altered by the decellularisation process. In this study, the contribution of GAGs to the tensile and compressive mechanical properties of pSFT was determined and whether decellularisation affected these properties by reducing GAG content or functionality. PSFTs were either enzymatically treated using chondroitinase ABC to remove GAGs or decellularised using previously established methods. Native, GAG-depleted and decellularised pSFT groups were then subjected to quantitative assays and biomechanical characterisation. In tension, specimens underwent stress relaxation and strength testing. In compression, specimens underwent confined compression testing. The GAG-depleted group was found to have a significantly lower GAG content than native and decellularised groups. There was no significant difference in GAG content between native and decellularised groups. Although stress relaxation testing discovered a reduction in the time-independent relaxation modulus in the decellularised group, there were no other significant differences between any of the groups for any of the remaining parameters assessed with stress relaxation or strength testing in tension. In compression testing, the aggregate modulus was found to be significantly lower in the GAG-depleted group than the native and decellularised groups, while the permeability was significantly higher in the GAG-depleted group than the decellularised group. The results indicate that GAGs significantly contribute to the mechanical properties of pSFT in compression, but not in tension. Furthermore, the content and function of GAGs in pSFTs are unaffected by decellularisation and the mechanical properties of the tissue are retained

Influence of Kinematics on the Wear of a Total Ankle Replacement

Total ankle replacement (TAR) is an alternative to fusion, replacing the degenerated joint with a mechanical motion-preserving alternative. Minimal pre-clinical testing has been reported to date and existing wear testing standards lack definition. Ankle gait is complex, therefore the aim of this study was to investigate the effect on wear of a range of different ankle gait kinematic inputs. Five Zenith (Corin Group) TARs were tested in a modified knee simulator for twelve million cycles (Mc). Different combinations of IR rotation and AP displacement were applied every 2Mc to understand the effects of the individual kinematics. Wear was assessed gravimetrically every Mc and surface profilometry undertaken after each condition. With the initial unidirectional input with no AP displacement the wear rate measured 1.2±0.6 mm3/Mc. The addition of 11° rotation and 9 mm of AP displacement caused a statistically significant increase in the wear rate to 25.8±3.1 mm3/Mc. These inputs seen a significant decrease in the surface roughness at the tibial articulation. Following polishing three displacement values were tested; 0, 4 and 9 mm with no significant difference in wear rate ranging 11.8–15.2 mm3/Mc. TAR wear rates were shown to be highly dependent on the addition of internal/external rotation within the gait profile with multidirectional kinematics proving vital in the accurate wear testing of TARs. Prior to surface polishing wear rates were significantly higher but once in a steady state the AP displacement had no significant effect on the wear