Polyetheretherketone (PEEK) interbody fusion cages combined with autologous bone graft is the current clinical gold standard treatment for spinal fusion, however, bone graft harvest increases surgical time, risk of infection and chronic pain. We describe novel low-stiffness 3D Printed titanium interbody cages without autologous bone graft and assessed their biological performance in a pre-clinical in vivo interbody fusion model in comparison to the gold standard, PEEK with graft. Titanium interbody spacers were 3D Printed with a microporous (Ti1: <1000μm) and macroporous (Ti2: >1000μm) design. Both Ti1 and Ti2 had an identical elastic modulus (stiffness), and were similar to the elastic modulus of PEEK. Interbody fusion was performed on L2-L3 and L4-L5 vertebral levels in 24 skeletally mature sheep using Ti1 or Ti2 spacers, or a PEEK spacer filled with iliac crest autograft, and assessed at 8 and 16 weeks. We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate. Functional spinal units were biomechanically tested to analyse range of motion, neutral zone, and stiffness. Results: Bone formation in macroporous Ti2 was significantly greater than microporous Ti1 treatments (p=.006). Fusion scores for Ti2 and PEEK demonstrated greater rates of bone formation from 8 to 16 weeks, with bridging rates of 100% for Ti2 at 16 weeks compared to just 88% for PEEK and 50% for Ti1. Biomechanical outcomes significantly improved at 16 versus 8 weeks, with no significant differences between Ti and PEEK with graft. This study demonstrated that macroporous 3D Printed Ti spacers are able to achieve fixation and arthrodesis with complete bone fusion by 16 weeks without the need for bone graft. These significant data indicate that low-modulus 3D Printed titanium interbody cages have similar performance to autograft-filled PEEK, and could be reliably used in spinal fusion avoiding the complications of bone graft harvesting

Massive irreparable rotator cuff tears often lead to superior migration of the humeral head, which can markedly impair glenohumeral kinematics and function. Although treatments currently exist for treating such pathology, no clear choice exists for the middle-aged patient demographic. Therefore, a metallic subacromial implant was developed for the purpose of restoring normal glenohumeral kinematics and function. The objective of this study was to determine this implant's ability in restoring normal humeral head position. It was hypothesized that (1) the implant would restore near normal humeral head position and (2) the implant shape could be optimized to improve restoration of the normal humeral head position. A titanium implant was designed and 3D printed. It consisted of four design variables that varied in both implant thickness (5mm and 8mm) and curvature of the humeral articulating surface (high constraint and low constraint. To assess these different designs, these implants were sequentially assessed in a cadaver-based biomechanical testing protocol. Eight cadaver specimens (64 ± 13 years old) were loaded at 0, 30, and 60 degrees of glenohumeral abduction using a previously developed shoulder simulator. An 80N load was equally distributed across all three deltoid heads while a 10N load was applied to each rotator cuff muscle. Testing states included a fully intact rotator cuff state, a posterosuperior massive rotator cuff tear state (cuff deficient state), and the four implant designs. An optical tracking system (Northern Digital, Ontario, Canada) was used to record the translation of the humeral head relative to the glenoid in both superior-inferior and anterior-posterior directions. Superior-Inferior Translation. The creation of a posterosuperior massive rotator cuff tear resulted in significant superior translation of the humeral head relative to the intact cuff state (P=0.016). No significant differences were observed between each implant design and the intact cuff state as all implants decreased the superior migration of the humeral head that was observed in the cuff deficient state. On average, the 5mm low and high constraint implant models were most effective at restoring normal humeral head position to that of the intact cuff state (-1.3 ± 2.0mm, P=0.223; and −1.5 ± 2.3mm, P=0.928 respectively). Anterior-Posterior Translation. No significant differences were observed across all test states for anterior-posterior translation of the humeral head. The cuff deficient on average resulted in posterior translation of the humeral head, however, this was not statistically significant (P=0.128). Both low and high constraint implant designs were found to be most effective at restoring humeral head position to that of the intact cuff state, on average resulting in a small anterior offset (5mm high constraint: 2.0 ± 4.7mm, P=1.000; 8mm high constraint: 1.6 ± 4.9mm, P=1.000). The 5mm high constraint implant was most effective in restoring normal humeral head position in both the superior-inferior and anterior-posterior directions. The results from this study suggest the implant may be an effective treatment for restoring normal glenohumeral kinematics and function in patients with massive irreparable rotator cuff tears. Future studies are needed to address the mechanical efficiency related to arm abduction which is a significant issue related to patient outcomes

Distal radius fractures have an incidence rate of 17.5% among all fractures. Their treatment in case of comminution, commonly managed by volar locking plates, is still challenging. Variable-angle screw technology could counteract these challenges. Additionally, combined volar and dorsal plate fixation is valuable for treatment of complex fractures at the distal radius. Currently, biomechanical investigation of the competency of supplemental dorsal plating is scant. The aim of this study was to investigate the biomechanical competency of double-plated distal radius fractures in comparison to volar locking plate fixation. Complex intra-articular distal radius fractures AO/OTA 23-C 2.1 and C 3.1 were created by means of osteotomies, simulating dorsal defect with comminution of the lunate facet in 30 artificial radii, assigned to 3 study groups with 10 specimens in each. The styloid process of each radius was separated from the shaft and the other articular fragments. In group 1, the lunate facet was divided to 3 equally-sized fragments. In contrast, the lunate in group 2 was split in a smaller dorsal and a larger volar fragment, whereas in group 3 was divided in 2 equal fragments. Following fracture reduction, each specimen was first instrumented with a volar locking plate and non-destructive quasi-static biomechanical testing under axial loading was performed in specimen's inclination of 40° flexion, 40° extension and 0° neutral position. Mediolateral radiographs were taken under 100 N loads in flexion and extension, as well as under 150 N loads in neutral position. Subsequently, all biomechanical tests were repeated after supplemental dorsal locking plate fixation of all specimens. Based on machine and radiographic data, stiffness and angular displacement between the shaft and lunate facet were determined. Stiffness in neutral position (N/mm) without/with dorsal plating was on average 164.3/166, 158.5/222.5 and 181.5/207.6 in groups 1–3. It increased significantly after supplementary dorsal plating in groups 2 and 3. Predominantly, from biomechanical perspective supplemental dorsal locked plating increases fixation stability of unstable distal radius fractures after volar locked plating. However, its effect depends on the fracture pattern at the distal radius

Previous biomechanical studies of lateral collateral ligament (LCL) injuries and their surgical repair, reconstruction and rehabilitation have primarily relied on gravity effects with the arm in the varus position. The application of torsional moments to the forearm manually in the laboratory is not reproducible, hence studies to date likely do not represent forces encountered clinically. The aim of this investigation was to develop a new biomechanical testing model to quantify posterolateral stability of the elbow using an in vitro elbow motion simulator. Six cadaveric upper extremities were mounted in an elbow motion simulator in the varus position. A threaded screw was then inserted on the dorsal aspect of the proximal ulna and a weight hanger was used to suspend 400g, 600g, and 800g of weight from the screw head to allow torsional moments to be applied to the ulna. An LCL injured (LCLI) model was created by sectioning of the common extensor origin, and the LCL. Ulnohumeral rotation was recorded using an electromagnetic tracking system during simulated active and passive elbow flexion with the forearm pronated and supinated. A repeated measures analysis of variance was performed to compare elbow states (intact, LCLI, and LCLI with 400g, 600g, and 800g of weight). During active motion, there was a significant difference between different elbow states (P=.001 pronation, P=.0001 supination). Post hoc analysis showed that the addition of weights did not significantly increase the external rotation (ER) of the ulnohumeral articulation (10°±7°, P=.268 400g, 10.5°±7.1°, P=.156 600g, 11°±7.2°, P=.111 800g) compared to the LCLI state (8.4°±6.4°) with the forearm pronated. However, with the forearm supinated, the addition of 800g of weight significantly increased the ER (9.2°±5.9°, P=.038) compared to the LCLI state (5.9°±5.5°) and the addition of 400g and 600g of weights approached significance (8.2°±5.7°, P=.083 400g, 8.7°±5.9°, P=.054 600g). During passive motion, there was a significant difference between different elbow states (P=.0001 pronation, P=.0001 supination). Post hoc analysis showed that the addition of 600g and 800g but not 400g resulted in a significant increase in ER of the ulnohumeral articulation (9.3°±7.8°, P=.103 400g, 11.2°±6.2°, P=.004 600g, 12.7°±6.8°, P=.006 800g) compared to the LCLI state (3.7°±5.4°) with the forearm pronated. With the forearm supinated, the addition of 400g, 600g, and 800g significantly increased the ER (11.7°±6.7°, P=.031 400g, 13.5°±6.8°, P=.019 600g, 14.9°±6.9°, P=.024 800g) compared to the LCLI state (4.3°±6.6°). This investigation confirms a novel biomechanical testing model for studying PLRI. Moreover, it demonstrates that the application of even small amounts of torsional moment on the forearm with the arm in the varus position exacerbates the rotational instability seen with the LCL deficient elbow. The effect of torsional loading was significantly worse with the forearm supinated and during passive elbow motion. This new model allows for a more provocative testing of elbow stability after LCL repair or reconstruction. Furthermore, this model will allow for smaller sample sizes to be used while still demonstrating clinically significant differences. Future biomechanical studies evaluating LCL injuries and their repair and rehabilitation should consider using this testing protocol

Aim. Treatment of infected and non-infected non-unions remain a major challenge after orthopedic fracture-related surgery. In clinical practice, several revision surgeries are usually required, including a radical debridement and exchange of implants, to control or even eradicate the infection to finally achieve bone healing. However, a clear treatment algorithm in clinical practice may be difficult to follow due to the heterogeneous patient population. Thus, so controlled settings for research purposes is better achieved in standardized animal studies. So far, there exists no multi-stage animal model that can be realistically transferred to the clinical situation in humans. The importance of such a model is obvious in order to be able to investigate different therapy concepts for infected and non-infected non unions. Methods. In 20 female Sprague-Dawley rats, a critical size defect by a femur osteotomy with 5 mm width was done. The periosteum at the fracture zone was cauterized proximal and distal to the osteotomy to achieve an hypovascularized situation. After randomization, 10 animals were intramedullary infected with a multisensible Staph. aureus strain (10. 3. CFU). After 5 weeks, a second surgery was performed with removing the K-wire, debridement of the osteotomy-gap and re-osteosynthesis with an angle-stable plate. After further 8 weeks all rats were euthanized and underwent biomechanical testing to evaluate bone consolidation or delayed union, respectively. Additional micro-CT analysis, histological, and histomorphometric analysis were done to evaluate bone consolidation or delayed union, respectively, by the score of Lane and Sandhu and to quantify callus formation and the mineralized area of the callus. Results. 5 weeks after the first surgery a non-union had formed in all septic and aseptic animals. According to the Lane and Sandhu score a significantly higher callus formation was found in the infected group. In all infected animals, the inoculated Staph. aureus strain was detected during the revision surgery. 8 weeks after the second surgery no bone healing could be detected in the µ-CT analysis in both groups and biomechanical testing showed a significant lower maximum torque in both groups as compared to the untreated contralateral femura. Conclusion. Here we show first results of a new two-stage pseudarthrosis animal model, which reflects a very realistic clinical situation of an infection-related non-union model. Based on this model, various therapeutic strategies in the treatment of infectious and non-infectious pseudarthrosis, such as the use of bone substitutes, can be evaluated in further studies

Proximal humeral fractures occur frequently, with fixed angle locking plates often being used for their treatment. However, the failure rate of this fixation is high, ranging between 10 and 35%. Numerous variables are thought to affect the performance of the fixation used, including the length and configuration of screws used and the plate position. However, there is currently limited quantitative evidence to support concepts for optimal fixation. The variations in surgical techniques and human anatomy make biomechanical testing prohibitive for such investigations. Therefore, a finite element osteosynthesis test kit has been developed and validated - SystemFix. The aim of this study was to quantify the effect of variations in screw length, configuration and plate position on predicted failure risk of PHILOS plate fixation for unstable proximal humerus fractures using the test kit. Twenty-six low-density humerus models were selected and osteotomized to create a malreduced unstable three-part fracture AO/OTA 11-B3.2 with medial comminution which was virtually fixed with the PHILOS plate. In turn, four different screw lengths, twelve different screw configurations and five plate positions were simulated. Each time, three physiological loading cases were modelled, with an established finite element analysis methodology utilized to evaluate average peri-screw bone strain, this measure has been previously demonstrated to predict experimental fatigue fixation failure. All three core variables lead to significant differences in peri-screw strain magnitudes, i.e. predicted failure risk. With screw length, shortening of 4 mm in all screw lengths (the distance of the screw tips to the joint surface increasing from 4 mm to 8 mm) significantly (p < 0 .001) increased the risk of failure. In the lowest density bone, every additional screw reduced failure risk compared to the four-screw construct, whereas in more dense bone, once the sixth screw was inserted, no further significant benefit was seen (p=0.40). Screw configurations not including calcar screws, also demonstrated significant (p < 0 .001) increased risk of failure. Finally, more proximal plate positioning, compared to the suggested operative technique, was associated with reduced the predicted failure risk, especially in constructs using calcar screws, and distal positioning increased failure risk. Optimal fixation constructs were found when placing screws 4 mm from the joint surface, in configurations including calcar screws, in plates located more proximally, as these factors were associated with the greatest reduction in predicted fixation failure in 3-part unstable proximal humeral fractures. These results may help to provide practical recommendations on the implant usage for improved primary implant stability and may lead to better healing outcomes for osteoporotic proximal fracture patients. Whilst prospective clinical confirmation is required, using this validated computational tool kit enables the discovery of findings otherwise hidden by the variation and prohibitive costs of appropriately powered biomechanical studies using human samples

An established rabbit model was used to preliminarily investigate the effect of acellular triphase, namely bone-cartilage-tendon, scaffold (ATS) sandwiched with autologous bone mesenchymal stem cells (BMSCs) sheets on tendon-bone interface healing. Bone, fibrocartilage and tendon tissue were harvested from the rabbits and sectioned into a book-type scaffold. The scaffolds were decellularized and their characterization was presented. BMSCs were isolated and co-cultured with the scaffolds to verify their cytocompatibility. BMSCs sheets were fabricated and inserted into the book page of the scaffold to construct an autologous BMSCs-sheets/book-type ATS complex. The complex was implated in the right knee of rabbits which operated standard partial patellectomy for TBI regeneration using Imaging, histological and biomechanical examinations. The bone, fibrocartilage and tendon tissue were sectioned into a book-type scaffold before decellularization. Then we decellularized the above tissue and mostly preserved their microstructure and composition of the natural extracellular matrix, including collagen and proteoglycan. After the physicochemical and biological properties of the book-type ATS were evaluated, autologous BMSCs sheets were inserted into the book page of the scaffold to construct an autologous BMSCs-sheets/book-type ATS implants for TBI regeneration. In addition, the ATS has the advantages of non-toxicity, suitable for cell adhesion and growth as well as low immunogenicity while co-cultured with the BMSCs. At the same time, different scaffolds has the ability to induce the osteogenic, chondrogenic and tenogenic differentiation of BMSCs by immunofluorescence, reverse transcription-polymerase chain reaction and western blot analysis. To determine the efficacy of the tissue-engineered implants for TBI regeneration, we transplanted it into a rabbit patella-patellar tendon (PPT) injury model, and the rabbits were sacrificed at postoperative week 8 or 16 for the radiological, histological, and mechanical evaluation. Radiologically, Synchrotron radiation micro-computed tomography (SR-μCT) showed that BMSCs/ATS group significantly increased bone area, BV/TV, trabecular thickness and trabecular number at the healing interface as compared with other groups at postoperative week 8 or 16. Histologically, the BMSCs/ATS group showed more woven bone, and a more robust fibrocartilaginous junction with a characteristic matrix rich in proteoglycans was seen at the PPT healing interface in comparison with other groups after 8 weeks. At week 16, the healing interface in 3 groups displayed better remodeling with respect to postoperative week 8. Healing and remodeling at the PPT junction were almost complete, with a resemblance to a healthy BTI consisting of the characteristic 4 zones in all groups. At last, we used biomechanical test as functional parameters to evaluate the quality of tendon-bone healing. Biomechanical testing indicated that BMSCs/ATS group showed significantly higher failure load and stiffness than other groups at postoperative week 8 and 16. The complex composed of acellular triphase, namely bone-cartilage-tendon, scaffold (ATS) sandwiched with autologous bone mesenchymal stem cells (BMSCs) sheets can simulate the gradient structure of tendon-bone interface, inducing stem cell directional differentiation, so as to promote patella-patellar tendon interface healing effectively after injury

Low back pain is more common in women than men, yet most studies of intervertebral disc (IVD) degeneration do not address sex differences. In humans, there are sex differences in spinal anatomy and degenerative changes in biomechanics, and animal models of chronic pain have demonstrated sex differences in pain transduction. However, there are few studies investigating sex differences in annular puncture IVD degeneration models. IVD puncture is known to result in progressive biomechanical alterations, but whether these IVD changes correlate with pain is unknown. This study used a rat IVD injury model to determine if sex differences exist in mechanical allodynia, biomechanics, and the relationship between them, six weeks after IVD injury. Procedures were IACUC approved. 24 male & 24 female four-month-old Sprague-Dawley rats underwent a sham or annular puncture injury surgery (n=12 male, 12 female). In injury groups, three lumbar IVDs were each punctured three times with a needle, and injected with tumor necrosis factor-alpha. Mechanical allodynia was tested biweekly using von Frey filaments. Six weeks after IVD injury, rats were euthanized and motion segments were dissected for non-destructive axial tension-compression and torsional rotation biomechanical testing. Two-way ANOVA with Bonferroni corrections identified statistically significant differences (p < 0 .05) and correlations used Pearson's coefficient. Annular puncture injury induced a significant increase in mechanical allodynia compared to sham in male but not female rats up to six weeks after injury. There was a significant sex effect on both torque range and torsional stiffness, with males exhibiting greater stiffness and torque range than females. Tensile stiffness, compressive stiffness, and axial range of motion showed no sex difference. Males and females showed similar patterns of correlation between variables when sham and injury groups were analyzed together, but correlations were stronger in males. Most correlations were clustered within testing approach: axial biomechanics negatively correlated, torsional biomechanics positively correlated, and von Frey thresholds positively correlated. Surprisingly, mechanical allodynia did not correlate with any biomechanics after injury, and the axial and torsional biomechanics showed little correlation. This study demonstrates that males and females respond to IVD injury differently. Given the absence of correlation between pain and biomechanics, pain cannot be attributed completely to biomechanical changes. This may explain why spinal fusion surgery, an intervention limited to the spine, has produced inconsistent results and is controversial for patients with low back pain. Thus, in addressing low back pain, we must consider both spinal tissues and the nervous system. Further, the limited correlation between axial and torsional biomechanics indicates that IVD injury may have distinct effects on nucleus pulposus and annulus fibrosus. Biomechanics did not differ between sham and injury at week six, suggesting healing after injury. It remains possible that acute biomechanical changes may initiate chronic pain pathogenesis. We conclude that the observed sex differences demonstrate the need for inclusion of both males and females in IVD injury and pain studies, and suggest that males and females may require different treatments for conditions that appear similar

Age-related fragility fractures are highly correlated with the loss of bone integrity and deteriorated morphology of the osteocytes. Previous studies have reported low-magnitude high-frequency vibration(LMHFV) promotes osteoporotic diaphyseal fracture healing to a greater extent than in age-matched normal fracture healing, yet how osteoporotic fractured bone responds to the mechanical signal has not been explored. As osteocytes are prominent for mechanosensing and initiating bone repair, we hypothesized that LMHFV could enhance fracture healing in ovariectomized metaphyseal fracture through morphological changes and mineralisation in the osteocyte Lacuno-canalicular Network(LCN). As most osteoporotic fractures occur primarily at the metaphysis, an osteoporotic metaphyseal fracture model was established. A total of 72 six-month old female Sprague-Dawley rats (n=72) were obtained(animal ethical approval ref: 16–037-MIS). Half of the rats underwent bilateral ovariectomy(OVX) and kept for 3 months for osteoporosis induction. Metaphyseal fracture on left distal femur was created by osteotomy and fixed by a plate. Rats were then randomized to (1) OVX+LMHFV(20 mins/day and 5 days/week, 35Hz, 0.3g), (2) OVX control, (3) SHAM+LMHFV, (4) SHAM control. Assessments of morphological structural changes, functional markers of the LCN(Scanning Electron Microscopy, FITC-Imaris, immunohistochemistry), mineralization status(EDX, dynamic histomorphometry) and healing outcomes(X-ray, microCT, mechanical testing) were performed at week 1, 2 and 6 post-fracture. One‐way ANOVA with post-hoc test was performed. Statistical significance was set at p < 0.05. Our results showed LMHFV could significantly enhance the morphology of the LCN. There was a 65.3% increase in dendritic branch points(p=0.03) and 93% increase in canalicular length(p=0.019) in the OVX-LMHFV group at week 2 post-fracture. Besides, a similar trend was also observed in the SHAM+LMHFV group, with a 43.4% increase in branch points and 53% increase in canaliculi length at week 2. A significant increase of E11 and DMP1 was observed in the LMHFV groups, indicating the reconstruction of the LCN. The decreasing sclerostin and increasing FGF23 at week 1 represented the active bone formation phase while the gradual increase at week 6 signified the remodelling phase. Furthermore, Ca/P ratio, mineral apposition rate and bone formation rate were all significantly enhanced in the OVX+LMHFV group. The overall bone mineral density in BV was significantly raised in the OVX+LMHFV group at week 2(p=0.043) and SHAM+LMHFV at week 6(p=0.04). Quantitative analysis of microCT showed BV/TV was significantly increased at week 2 in OVX+LMHFV group(p=0.008) and week 6(p=0.001) in both vibration groups. In addition, biomechanical testing revealed that the OVX+LMHFV group had a significantly higher ultimate load(p=0.03) and stiffness(p=0.02) at week 2. To our best knowledge, this is the first report to illustrate LMHFV could enhance osteocytes' morphology, mineralisation status and healing outcome in a new osteoporotic metaphyseal fracture animal model. Our cumulative data supports that the mechanosensitivity of bone would not impair due to osteoporosis. The revitalized osteocyte LCN and upregulated osteocytic protein markers implied a better connectivity and transduction of signals between osteocytes, which may foster the osteoporotic fracture healing process through an enhanced mineralisation process. This could stimulate further mechanistic investigations with potential translation of LMHFV to our fragility fracture patients

Introduction and Aims. Clinically many factors such as variations in surgical positioning, and patients' anatomy and biomechanics can affect the occurrence and severity of edge loading which may have detrimental effect on the wear and durability of the implant. Assessing wear of hundreds of combinations of conditions would be impractical, so a preclinical testing approach was followed where the occurrence and severity of edge loading can be determined using short biomechanical tests. Then, selected conditions can be chosen under which the wear can be determined. If a wear correlation with the magnitude of dynamic separation or the severity of edge loading can be shown, then an informed decision can be made based upon the biomechanical results to only select important variables under which the tribological performance of the implant can be assessed. The aim of this study was to determine the relationship between the wear of ceramic-on-ceramic bearings and the (1) magnitude of dynamic separation, (2) the maximum force reached during edge loading and (3) the severity of edge loading resulting from component translational mismatch between the head and cup centres. Methods. The Leeds II hip joint simulator with a standard walking cycle and 36mm diameter ceramic-on-ceramic bearings (BIOLOX. ®. delta, DePuy Synthes Joint Reconstruction, Leeds, UK.) were used. The study was in two parts. Part one: a biomechanical study where the dynamic separation, the maximum load during edge loading, and the duration of edge loading alongside the magnitude of forces under edge loading (severity of edge loading) were assessed. Part two; a wear study where the wear rates of the bearing surfaces were assessed under a series of input conditions. These input testing conditions included inclining the acetabular cups at 45° and 65° cup inclination angle (in-vivo equivalent), with 2, 3, and 4mm medial-lateral component mismatch between the centres of the head and the cup. This equated to six conditions being assessed, each with three repeats for the biomechanical test, and six repeats completed for the wear study. The severity of edge loading was assessed as described in Equation 1. Severity of Edge Loading = ∫. t. t0. F(x) dx + ∫. t. t0. F(y) dy … Equation 1,. where F(x) is the axial load, F(y) is the medial-lateral load and t-t0 is the duration of edge loading. The wear of the ceramic bearings were determined using gravimetric analysis (XP205, Mettler Toledo, UK). Results. The wear rates of ceramic-on-ceramic bearings increased as the magnitude of dynamic separation (Figure 1), the maximum load at the rim during edge loading (Figure 2), and the severity of edge loading (Figure 3) increased. The magnitude of dynamic separation was found to have the highest correlation to the wear rate under the conditions tested in this study (R. 2. =0.94). Conclusions. A preclinical testing approach has been developed to understand the occurrence and severity of edge loading associated with variation of component positioning. A good correlation was found between the wear rates obtained for ceramic-on-ceramic bearings and the magnitude of parameters obtained under edge loading during a short-term biomechanical study. For figures/tables, please contact authors directly.

Introduction. Variations in component position can lead to dynamic separation and edge loading conditions. In vitro methods have been developed to simulate edge loading conditions and replicate stripe wear, increased wear rate, and bimodal wear debris size distribution, as observed clinically [1, 2]. The aim of this study was to determine the effects of translational and rotational positioning on the occurrence of dynamic separation and severity of edge loading, and then investigate the wear rates under the most severe separation and edge loading conditions on an electromechanical hip joint simulator. Materials and Methods. A hip joint simulator (ProSim EM13, Simulation Solutions, UK) was set up with 36mm diameter ceramic-on-ceramic (BIOLOX®delta, PINNACLE®, DePuy Synthes, UK) hip replacements. Three axes of rotation conditions (ISO 14242-1 [3]) was applied to the femoral head. This study was in two parts. I) A biomechanical test was carried out at 45° (n=3) and 65° (n=3) cup inclination angles with 1, 2, 3 and 4 (mm) medial-lateral translational mismatch between the centres of the head and cup. The amount of dynamic separation displacement between the head and cup was measured using a position sensor. The severity of edge loading was determined from the area under the axial force and medial-lateral force outputs during the time of separation [4]. II) A wear test was carried out at 45° (n=6) and 65° (n=6) cup inclination angles for three million cycles with translational mismatch of 4mm between the head and cup. The lubricant used was diluted new-born calf serum (25% v/v). Volumetric wear measurements were undertaken at one million cycle intervals and mean wear rates were calculated with 95% confidence limits. Statistical analysis was carried out using ANOVA and a t-test with significance levels taken at p<0.05. Results. Dynamic separation increased significantly with 3mm (p<0.01) and 4mm (p<0.01) translational mismatch at a 45° cup inclination angle (Figure 1). At 65° the separation increased significantly as the translational mismatch increased from 1mm to 4mm (p<0.01). The most severe edge loading conditions occurred at a 65° cup inclination angle with 4mm of translational mismatch (p<0.01, Figure 2). Mean wear rates were greater at a 65° cup inclination angle compared with a 45° cup inclination angle (p<0.01, Figure 3). Conclusion. Different levels of rotational and translational mismatch affected the separation between the head and cup during gait. Higher levels of translational mismatch and a steeper cup inclination angle may lead to more severe edge loading conditions and increased wear of ceramic-on-ceramic bearings in vivo. A new preclinical testing approach was developed to study the effects of edge loading due to variations in rotational and translational surgical positioning under ISO loading and angular displacement conditions. The first stage comprised of biomechanical tests to determine the occurrence and severity of edge loading in a range of component positions. The second stage investigated the tribological performance of the bearing surface under the worst case edge loading conditions

Aim. Silver is known for its excellent antimicrobial activity, including activity against multiresistant strains. The aim of the current study was to analyze the biocompatibility and potential influence on the fracture healing process a silver-coating technology for locking plates compared to silver-free locking plates in a rabbit model. Methods. The implants used in this study were 7-hole titanium locking plates, and plasma electrolytic oxidation (PEO) silver coated equivalents. A total of 24 rabbits were used in this study (12 coated, 12 non-coated). An osteotomy of the midshaft of the humerus was created with an oscillating saw and the humerus stabilized with the 7 hole locking plates with a total of 6 screws. X-rays were taken on day 0, week 2, 4, 6, 8, and 10 for continuous radiographical evaluation of the fracture healing. All animals were euthanized after 10 weeks and further assessment was performed using X-rays, micro-CT, non-destructive four-point bending biomechanical testing and histology. Furthermore, silver concentration was measured in the kidney, liver, spleen and brain. Results. X-rays showed normal undisturbed healing of the osteotomy in all animals without any differences between the two groups over the entire X-ray analysis over 10 weeks (Figure 1). Callus formation was observed up to week 4 to 5 followed by callus remodeling after 6 weeks indicating physiological fracture healing pattern in both the silver and in the silver free group. Micro CT analysis revealed overall tissue (callus and cortical bone) volume as well as tissue density to be comparable between the two groups. Mechanical testing showed comparable stiffness with an average stiffness relative to contralateral bones of 75.7 ± 16.1% in the silver free control group compared to 69.7 ± 18.5% (p-value: 0.46). Histology showed no remarkable difference in the analysis of the healed osteotomy gap or in the surrounding soft tissue area. Silver content was found to be close to baseline values without differences between the two groups. Conclusions. This study shows that the presented antimicrobial silver surface modification for locking plates has a good biocompatibility without any negative influence on the fracture healing processes compared to the silver free control group. This allows for further clinical investigation of this silver technology for locking plates in fracture patients with an elevated infection risk, e.g. in patients with open fractures. For any figures or tables, please contact the authors directly

Introduction. Total Elbow Arthroplasty (TEA) is recognized as an effective treatment solution for patients with rheumatoid arthritis or for traumatic conditions. Current total elbow devices can be divided into linked or unlinked design. The first design usually presents a linking element (i.e. an axle) to link together the ulnar and humeral components to stabilize the joint; the second one does not present any linkage and the stability is provided by both intrinsic design constraints and the soft tissues. Convertible modular solutions allow for an intraoperative decision to link or unlink the prosthesis; the modular connections introduce however additional risks in terms of both mechanical strength and potential fatigue and fretting phenomena that may arise not only due to low demand activities loads, but also high demand (HD) ones that could be even more detrimental. The aim of this study was to assess the strength of the modular connection between the axle and the ulnar component in a novel convertible elbow prosthesis design under simulated HD and activities of daily living (ADLs) loading. Methods. A novel convertible total elbow prosthesis (LimaCorporate, IT) comprising both ulnar and humeral components that can be linked together by means of an axle, was used. Both typical ADLs and HD torques to be applied to the axle were determined based on finite element analysis (FEA); the boundary load conditions for the FEA were determined based on kinematics analysis on real patients in previous studies. The FEA resultant moment acting on the axle junction during typical ADLs (i.e. feeding with 7.2lbs weight in hand) was 3.2Nm while for HD loads (i.e. sit to stand) was 5.7 Nm. In the experimental setup, 5 axle specimens coupled with 5 ulnar bodies through a tapered connection (5 Nm assembly torque) were fixed to a torque actuator (MTS Bionix) and submerged in a saline solution (9g/l). A moment of 3.2 Nm was applied to the axle for 5M cycles through a fixture to test it under ADLs loading. After 5M cycles, the axles were analyzed with regards to fretting behavior and then re-assembled to test them against HD loading by applying 5.7 Nm for 200K cycles (corresponding to 20 years function). Results. All 5 samples withstood all 5.2M loading cycles without any mechanical failure. At the end of 5M cycles, each axle was still stable as the measured disassembly torque was 3.96 +/−0.18 Nm. Slight signs of fretting were detected on the tapered connection after 5M cycles, however they did not compromise the mechanical connection nor the stability. Discussion and Conclusions. Currently there are no reference standards that properly define protocols for biomechanical testing of elbow prostheses. In the present study, a test to mechanically assess the strength of an axle connection under both typical ADLs and HD loads was set. The connection was able to withstand the imposed conditions. In general, testing of TEA devices should include not only standard ADLs loads but also HD loads, which could be more detrimental for the long-term survivorship. For any figures or tables, please contact authors directly

Introduction. Concerning biomechanical research, human specimens are preferred to achieve conditions that are close to the clinical situation. On the other hand, synthetic femurs are used for biomechanical testing instead of fresh-frozen human femurs, to create standardized and comparable conditions. A new generation of synthetic femurs is currently available aiming to substitute the validated traditional one. Structural femoral properties of the new generation have already been validated, yet a biomechanical validation is missing. The aim of our study was to analyse potential differences in the biomechanical behaviour of two different synthetic femoral designs by measuring the primary rotational stability of a cementless femoral hip stem. Methods. The cementless SL-PLUS® standard stem (size 6, Smith&Nephew Orthopaedics AG, Rotkreuz, Swizerland) was implanted in two groups of synthetic femurs. Group A consists of three 2. nd. generation femurs and group B consists of three 4. th. generation femurs (both: size large, composite bone, Sawbones® Europe, Malmö, Sweden). Using an established method to analyse the rotational stability, a cyclic axial torque of ±7.0 Nm along the longitudinal stem axis was applied. Micromotions were measured at defined levels of the bone and the implant. The calculation of relative micromotions at the bone-implant interface allowed classifying the rotational implant stability. Results. Lowest relative micromotions were located near the isthmus for both designs (2. nd. 3.47 ± 1.43 mdeg/Nm and 4. th. 5.97 ± 0.39 mdeg/Nm), whereas highest relative micromotions were located at distal tip for both designs (2. nd. 8.42 ± 1.38 mdeg/Nm and 4. th. 8.40 ± 0.39 mdeg/Nm). No statistically significant differences were found between 2. nd. and 4. th. generation femurs in the distal part (2. nd. 8.42 ± 1.38 mdeg/Nm and 4. th. 8.40 ± 0.39 mdeg/Nm; p>0.05), but proximally (2. nd. 3.63 ± 1.10 mdeg/Nm vs. 4. th. 6.55 ± 1.27 mdeg/Nm; p<0.05). Compared to the 2. nd. generation, the 4. th. generation femur resulted in less absolute micromotions and less standard deviation of micromotions. Discussion. Compared to other implant designs, the SL-PLUS® stem resulted in low relative motions regardless the used synthetic femur. Within the two distal measuring levels, no significant differences could be observed. Proximally, at the level of the Trochanter minor, mean relative motions nearly doubled from group A to B. However, the anchorage principle of the SL-PLUS® stem was still similar in both synthetic femurs. Qualitatively, both synthetic femurs revealed a proximal fixation of the stem. Although the values of relative motion slightly differs, 4. th. generation synthetic femurs are suitable to achieve similar results for measuring the primary stability of cementless femoral hip stems compared to 2. th. generation synthetic femurs. Future measurements with human specimens should validate weather one of the synthetic bone models is closer to the human situation. Within this study we could show that the new 4. th. generation synthetic femur designs could qualitatively give comparable results to older synthetic bone models regarding biomechanical tests, like primary stability measurements on cementless hip stems

Surgical failure, mainly caused by loosening implants, causes great mental and physical trauma to patients. Improving the physicochemical properties of implants to achieve favourable osseointegration will continue to be the focus of future research. Strontium (Sr), a trace element, is often incorporated into hydroxyapatite (HA) to improve its osteogenic activity. Our previous studies have shown that miR-21 can promote the osteogenic differentiation of mesenchymal stem cells by the PI3K/β-catenin pathway. The aim of this study is to fabricate a SrHA and miR-21 composite coating and it is expected to have a favorable bone healing capability. Ti discs (20 mm diameter and one mm thickness for the in vitro section) and rods (four mm diameter and seven mm length for the in vivo section) were prepared by machining pure Ti. The Ti cylinders were placed in a Teflon-lined stainless-steel autoclave for treating at 150°C for 24 h to form SrHA layer. The miR-21 was encapsulated in nanocapsules. The miR-21 nanocapsules were mixed with CMCS powder to form a gel-like sample and uniformly coated on the SrHA modifed Ti. Osteoblast-like MG63 cells were cultured on SrHA and miR-21 modified Ti, Cell proliferation activity and osteogenesis-related gene expression were evaluated. A bone defect model was established with mature New Zealand to evaluate the osseointegration. Cylindrical holes (four mm in diameter) were created at the distal femur and tibial plateau. Each rabbit was implanted with four of the aforementioned rods (distal femur and tibial plateau of the hind legs). After implantation for one, two and three months, the rabbits were observed by X-ray and scanned using u-CT. Histological and Immunohistochemical analysis were performed to examine the osteogenic markers. A biomechanical push-in test was used to assess the bone-implant bonding strength. Both SrHA nanoparticles with good superhydrophilicity and miR-21 nanocapsules with uniform sizes were distributed evenly on the surface of the Ti. In vitro experiments revealed that the composite coating was beneficial to osteoblast proliferation, differentiation and mineralization. In vivo evaluations demonstrated that this coating could not only promote the expression of angiogenic factor CD31 but also enhance the expression of osteoblastic genes to facilitate angio-osteogenesis. In addition, the composite coating also showed a decreased RANKL expression compared with the miR-21 coating. As a result, the SrHA/miR-21 composite coating promoted new bone formation and mineralization and thus enhanced osseointegration and bone-implant bonding strength. A homogeneous SrHA and miR-21 composite coating was fabricated by generating pure Ti through a hydrothermal process, followed by adhering miR-21 nanocapsules. This coating combined the favorable physicochemical properties of SrHA and miR-21 that synergistically promoted angiogenesis, osteogenesis, osseointegration, bone mineralization and thus bone-implant bonding strength. This study provided a new strategy for surface modification of biomedical implants

Introduction and Aims. There are many surgical, implant design and patient factors that should be considered in preclinical testing of hip replacement which are not being considered in current standards. The aim of this study was to develop a preclinical testing method that consider surgical positioning, implant design and patient factors and predict the occurrence and severity of edge loading under the combination of such conditions. Then, assess the safety and reliability of the implant by predicting the wear, deformation and damage of the implant bearings under worst case conditions. Methods. Ceramic-on-ceramic (CoC, 36mm, BIOLOX. ®. delta, Pinnacle. ®. , DePuy Synthes, UK) and metal-on polyethylene (MoP, 36mm, Marathon®, Pinnacle. ®. , DePuy Synthes, UK) bearings were used for this study on multi-station multi-axis hip joint simulators. Two factors were varied, cup inclination angles (45° and 65°) and translational mismatch between the femoral head and acetabular cup (0, 2, 3 and 4 (mm)). Under each condition for both CoC and MoP bearings, three million cycles of gait cycle testing were completed with wear, deformation and/or damage measurements completed at one million cycle intervals. Other outputs of the study were the level of dynamic separation between the femoral head and acetabular cup during gait, the maximum force at the rim during edge loading when the head was sliding back to the cup confinement. Means and 95% confidence limits were determined and statistical analysis were done using one way ANOVA with significance taken at p<0.05. Results. As the level of mismatch and the cup inclination angle increased, the magnitude of dynamic separation and the force at the rim increased. The level of dynamic separation and the force on the rim correlated with the wear of CoC bearings (R= 0.96). For polyethylene, steeper inclination angle did not significantly increase the wear (p>0.05) however, edge loading under 4mm translational mismatch and steep cup inclination angle did (p<0.01). The combined wear and deformation of the polyethylene liners at the rim increased under larger levels of dynamic separation. Conclusions. The magnitude of dynamic separation and force at the rim were predictive of the severity of edge loading. These parameters can be measured using short term testing (500 cycles). This will determine the effect of variations in surgical positioning, implant design and patient factors on the occurrence and severity of edge loading. Then, the wear, deformation and/or damage on hip replacement bearings can be determined using longer term simulator testing under selected conditions. The short term tests do not only help identify worst case scenarios but may identify the boundary of surgical position under which the implants performance may be considered acceptable. A new approach for preclinical testing of hip replacement was developed:. Stage 1: Short biomechanical tests. : assess the occurrence and severity of edge loading conditions where the outputs are:. Magnitude of medial-lateral dynamic separation. Maximum force under edge loading. Stage 2: Wear assessment. : assess the tribological performance of hip replacement under selected conditions where the outputs are:. Wear rates. Deformation and/or damage on the bearing surface

Bone marrow concentrates are being used to augment soft tissue healing. However, only 0.01% of these cells meet the criteria of a mesenchymal stem cell (MSC), which likely accounts for the variability in reported results. Previous studies using an established rat rotator cuff repair model have demonstrated that bone marrow-derived MSCs had no effect on healing. In this study we evaluated the effect of purified human MSCs on rotator cuff healing in an athymic rat model. Hypothesis: Purified human MSCs added to the repair site will improve biomechanical strength and fibrocartilage formation of the healing tendon. Fifty-two athymic rats underwent unilateral detachment and repair of the supraspinatus tendon with either fibrin glue (control) or fibrin glue with 106 hMSCs (experimental) applied at the repair site. Flow cytometry verified the stem cell phenotype of the cells as CD73+, CD90+, CD105+, CD14-, CD34- and CD45-. Rats were sacrificed at 2 and 4 weeks, with 10 used for biomechanical testing and 3 for histologic analysis from each group. Biomechanical testing revealed a significant increase in failure load (11.5±2.4N vs. 8.5±2.4N, p=0.002) and stiffness (7.1±1.2 N/mm vs. 5.7±2.1 N/mm, p0.17). These data demonstrate the potential for stem cells to augment tendon healing. This is the first study to use purified stem cells, rather than simple bone marrow concentrate. In the future, cell sorting techniques and culture expansion could be used to select and expand the small population of true stem cells in bone marrow. Furthermore, healing could potentially be improved with repeat cell injection at an additional post-operative time point

Introduction. Revision Total Hip Arthroplasties (THA) have a significantly higher failure rate than primary THA's and the most common cause is aseptic loosening of the cup. To reduce this incidence of loosening various porous metal implants with a rough surface and a porous architecture have been developed which are said to increase early osteointegration. However, for successful osteointegration a minimal micromotion between the implant and the host bone (primary stability) is beneficial. It has not been previously determined if the primary stability for the new Gription® titanium cup differs from that of the old Porocoat® titanium cup. Material and Methods. In 10 cadaveric pelvises, divided into 20 hemipelvises, bilateral THA's were performed by an experienced surgeon (RGB) following the implant manufacturer's instructions and with the original surgical instruments provided by the company. In randomized fashion the well established Porocoat® titanium implant was implanted on one side of each each hemipelvis whereas on the corresponding opposite side the modified implant with a Gription® coating was inserted. Radiographs were taken to confirm satisfactory operative results. Subsequently, the hemipelvis and cups were placed in a biomechanical testing machine and subjected to physiological cyclic loading. Three-dimensonal loading corresponded to 30% of the load experienced in normal gait was imposed reflecting the limited weight bearing generally prescribed postoperatively. The dynamic testing took place in a multi-axial testing machine for 1000 cycles. Relative motion and micromotion were quantified using an optical measurement device (Pontos, GOM mbh, Braunschweig, Germany). Statistical evaluation was performed using the Wilcoxon signed-rank test. Results and conclusion. The standard Porocoat® titanium cups showed a mean relative motion with respect to the host bone of 54.74µm (Range 26.04 – 127.06µm), while the porous Gription® titanium cup displayed a relative motion with respect to the host bone of 49.77µm (Range 24.69 – 128.37µm). The Wilcoxon test did not reveal a significant difference between the two surfaces. The in-vitro biomechanical evaluation of both acetabular cups under a physiologic loading scenario showed no significant difference with regard to primary stability. Both the extensively tried and clinically successful Porocoat® titanium cup and the newer Gription® coated cup showed very little micromotion and both implants should therefore allow good osteointegration

Restoring the overall mechanical alignment to neutral has been the gold standard since the 1970s and remains the current standard of knee arthroplasty today. Recently, there has been renewed interest in alternative alignment goals that place implants in a more “physiologic” position with the hope of improving clinical outcomes. Anywhere from 10 – 20% of patients are dissatisfied after knee replacement surgery and while the cause is multifactorial, some believe that it is related to changing native alignment and an oblique joint line (the concept of constitutional varus) to a single target of mechanical neutral alignment. In addition, recent studies have challenged the long held belief that total knee placed outside the classic “safe zone” of +/− 3 degrees increases the risk of mechanical failure which theoretically supports investigating alternative, more patient specific, alignment targets. From a biomechanical, implant retrieval, and clinical outcomes perspective, mechanical alignment should remain the gold standard for TKA. Varus tibias regardless of overall alignment pattern show increased polyethylene wear and varus loading increases the risk of posteromedial collapse. While recently questioned, the evidence states that alignment does matter. When you combine contemporary knee designs placed in varus with an overweight population (which is the majority of TKA patients) the failure rate increases exponentially when compared to neutral alignment. A recent meta-analysis on mechanical alignment and survivorship clearly demonstrated reduced survivorship for varus-aligned total knees. The only way to justify the biomechanical risks associated with placing components in an alternative alignment target is a significant clinical outcome benefit but the evidence is lacking. A randomised control trial comparing mechanical alignment (MA) and kinematic alignment (KA) found a significant improvement in clinical outcomes and knee function in KA patients at 2 year follow-up. In contrast, Young et al. recently published a randomised control trial comparing PSI KA and computer assisted mechanical TKA and found no difference in any clinical outcome measure. Why were the clinical outcomes scores in the MA patients so different: One potential explanation is that different surgical techniques were used. In the Dosset study, the femur was cut at 5 degrees valgus in all patients and femoral component rotation was always set at 3 degrees externally rotated to the posterior condylar axis. We know from several studies that this method leads to inaccuracies in both coronal plane and axial plane in some patients. Young et al. used computer assisted navigation to align his distal femur cut with the mechanical axis and adjusted femoral component rotation to the transepicondylar axis. The results suggest that a well performed mechanical aligned total knee replacement has excellent clinical performance equal to that of kinematic alignment without any of the long term risks of implant failure. Most contemporary TKA implants are designed to be loaded perpendicular to the polyethylene surface and placing them in shear without extensive biomechanical testing to support this alignment target may put patients at long term risk for an unproven benefit. Have we not learned our lesson?

Fixation of tendon transfers about the foot in children typically involves creating a bone tunnel through which a suture is passed and tied over an external button. An internal suspension system, such as the Endobutton (Smith & Nephew) is an alternative fixation method which has demonstrated excellent fixation strength and minimal intraosseous tunnel displacement in various adult procedures. Application of the Endobutton technique has no risk of skin ulceration, does not require suture removal and may provide more secure fixation. The purpose of this study is to compare the biomechanical properties of the external button and Endobutton fixation techniques. Our primary outcome measure was intra-osseous displacement of the suture, during both static and dynamic loading, in cadaver feet. Nine adult cadaver feet were utilised. A bone tunnel was drilled in the lateral cuneiform and #1 braided non-absorbable suture was passed through the tunnel. One end was secured to a carabiner to be attached to the materials testing system and the other to the fixation device. The external button and Endobutton fixation techniques were tested once in each cadaver, randomising the order of testing to minimise bias. Each fixation technique underwent static and dynamic cyclic loading. A custom Matlab script was used to process video and materials testing system data. The relative displacement of the suture within the bone tunnel, as a function of time and load magnitude, was recorded during static and dynamic cyclic loading. Both fixation groups were analysed and compared for statistical significance using a paired T-test and an alpha value of 0.05. The Endobutton group had significantly less displacement within the bone tunnel, during both static and dynamic loading, than the external button. The average displacement during static loading was 0.42 mm for the Endobutton and 2.17 mm for the external button (p=0.0019). Similarly, during dynamic cyclic loading, the mean displacement was 0.32 mm for the Endobutton and 0.66 mm for the external button (p=0.0115). The Endobutton internal suspension technique demonstrates significantly less displacement during static and dynamic loading than the external button, during biomechanical testing in cadaver feet. The Endobutton may provide superior fixation than the traditional external button technique for tendon transfers in children. In addition, this technique avoids the risk of skin ulceration from the button and the need for suture removal