Among the advanced technology developed and tested for orthopaedic surgery, the Rizzoli (IOR) has a long experience on custom-made design and implant of devices for joint and bone replacements. This follows the recent advancements in additive manufacturing, which now allows to obtain products also in metal alloy by deposition of material layer-by-layer according to a digital model. The process starts from medical image, goes through anatomical modelling, prosthesis design, prototyping, and final production in 3D printers and in case post-production. These devices have demonstrated already to be accurate enough to address properly the specific needs and conditions of the patient and of his/her physician. These guarantee also minimum removal of the tissues, partial replacements, no size related issues, minimal invasiveness, limited instrumentation. The thorough preparation of the treatment results also in a considerable shortening of the surgical and of recovery time. The necessary additional efforts and costs of custom-made implants seem to be well balanced by these advantages and savings, which shall include the lower failures and revision surgery rates. This also allows thoughtful optimization of the component-to-bone interfaces, by advanced lattice structures, with topologies mimicking the trabecular bone, possibly to promote osteointegration and to prevent infection. IOR's experience comprises all sub-disciplines and anatomical areas, here mentioned in historical order. Originally, several systems of Patient-Specific instrumentation have been exploited in total knee and total ankle replacements. A few massive osteoarticular reconstructions in the shank and foot for severe bone fractures were performed, starting from mirroring the contralateral area. Something very similar was performed also for pelvic surgery in the Oncology department, where massive skeletal reconstructions for bone tumours are necessary. To this aim, in addition to the standard anatomical modelling, prosthesis design, technical/technological refinements, and manufacturing, surgical guides for the correct execution of the osteotomies are also designed and 3D printed. Another original experience is about en-block replacement of vertebral bodies for severe bone loss, in particular for tumours. In this project, technological and biological aspects have also been addressed, to enhance osteointegration and to diminish the risk of infection. In our series there is also a case of successful custom reconstruction of the anterior chest wall. Initial experiences are in progress also for shoulder and elbow surgery, in particular for pre-op planning and surgical guide design in complex re-alignment osteotomies for severe bone deformities. Also in complex flat-foot deformities, in preparation of surgical corrections, 3D digital reconstruction and 3D printing in cheap ABS filaments have been valuable, for indication, planning of surgery and patient communication; with special materials mimicking bone strength, these 3D physical models are precious also for training and preparation of the surgery. In Paediatric surgery severe multi planar & multifocal deformities in children are addressed with personalized pre-op planning and custom cutting-guides for the necessary osteotomies, most of which require custom allografts. A number of complex hip revision surgeries have been performed, where 3D reconstruction for possible final solutions with exact implants on the remaining bone were developed. Elective surgery has been addressed as well, in particular the customization of an original total ankle replacement designed at IOR. Also a novel system with a high-tibial-osteotomy, including a custom cutting jig and the fixation plate was tested. An initial experience for the design and test of custom ankle & foot orthotics is also in progress, starting with 3D surface scanning of the shank and foot including the plantar aspect. Clearly, for achieving these results, multi-disciplinary teams have been formed, including physicians, radiologists, bioengineers and technologists, working together for the same goal

It is well documented that implant loosening rate in sickle cell disease patients is higher than that seen in patients with hip arthroplasty from other indications. The Hypoxic inducible factor(HIF) - is activated in the microcellular hypoxic environment and this through a cascade of other enzymatic reactions promotes the activity of other factors and further help enhance angiogenesis and osteogenesis. The aim of this study was to investigate and propose a potential model for investigating osseointegration in a hypoxic microcellular environment using osteoblasts(MG63). Human MG63 osteoblastic cells were cultured under normoxia and hypoxic conditions (20%; and 1% oxygen saturation) for 72 hours under two different condition- with and without cobalt chloride. The samples cultured under normoxic condtions without cobalt chloride acted as control. Using qualitative polymerase chain reaction-(qPCR) - HIF expression was assessed under the above conditions in relation to the control. The results showed there was significant expression of the HIF 1 alpha protein under hypoxic condition with cobalt chloride in comparison with the control samples- all at 72hours incubation. Mann-Whitney U test was used to deduce level of significance of fold change.(p=0.002; <0.05). This was deemed as being a significant difference in the level of expression of HIF compared to the control. The results show that the hypoxic inducible factor can be expressed using the above tested. experimental invitro-model with significant results which can be a foundation for further research into improving hip implant prosthesis design to help enhance osseo-integration in sickle cell disease patient with AVN

Arthritis of the glenohumeral joint accompanied by an irreparable tear of the rotator cuff can cause severe pain, disability and loss of function, particularly in the elderly population. Anatomical shoulder arthroplasty requires a functioning rotator cuff, however, reverse shoulder arthroplasty is capable of addressing both rotator cuff disorders and glenohumeral deficiencies. The Aequalis Reversed Shoulder Prosthesis design is based on two bio-mechanical principles by Grammont; a medialized center of rotation located inside the glenoid bone surface and second, a 155 degree angle of inclination. Combined, they increase the deltoid lever arm by distalizing the humerus and make the prosthesis inherently stable. 24 consecutive primary reverse total shoulder arthroplasties were performed by a single surgeon for arthritis with rotator cuff compromise and 1 as a revision for a failed primary total shoulder replacement between December 2009 and October 2012. Patients were assessed postoperatively with the use of the DASH score, Oxford shoulder score, range of shoulder motion and plain radiography with Sirveaux score for scapular notching. Mean age at the time of surgery was 72.5 years (range 59 to 86). Average follow up time was 19.4 months (range 4 to 38). Functional outcome scores from our series were comparable with patients from other follow up studies of similar prosthesis design. All patients showed improvement in range of shoulder movement postoperatively. Complications included one dislocation, one acromion fracture and one humeral shaft fracture. No cases of deep infection were recorded. Overall, the short-term clinical results were promising for this series of patients and indicate reverse shoulder arthroplasty as an appropriate treatment for this group of patients

Summary Statement. The constraint behavior of total knee arthroplasty (TKA) prosthesis usually has to be physically tested. This study presents a computer simulation model using finite element analysis (FEA) and demonstrates its effectiveness in predicting the femorotibial constraint behavior of TKA implants. Introduction. TKA prostheses are semi-constrained artificial joints. A well-functioning TKA prosthesis should be designed with a good balance between stability and mobility, meaning the femorotibial constraint of the artificial joint cannot be excessive or too lax. To assess the constraint behavior of a TKA prosthesis, physical testing is usually required, and an industrial test standard has been developed for this purpose. Benefiting from technological advancement, computer simulation has become increasingly useful in many industries, including medical device research and development. FEA has been extensively used in stress analysis and structural evaluation of various orthopaedic implants. This study presented an FEA-based simulation to evaluate the femorotibial constraint behavior of TKA prosthesis, and demonstrated the effectiveness of the method by validating it through physical testing. Methods. A Cruciate Retaining (CR) TKA prosthesis design (Optetrak Logic CR, size 3, Exactech, FL, USA) was used in this study. The prosthesis system consists of a femoral component, a tibial insert, and a tibial baseplate. CAD models of the implants assembled at 0° of flexion were used for the simulation. Finite element models were generated using 10-node tetrahedral elements, with all materials considered linear elastic. Boundary conditions were set up according to the ASTM F1223 standard. The tibial baseplate was fixed distally. A constant compressive force (710 N) was applied on the femoral component. Nonlinear Surface-Surface-Contact was defined at the femorotibial articulating surfaces as well as between the tibial insert and tibial baseplate. A coefficient of friction of 0.2 determined from the physical test was input into the simulation. The femoral component was driven under a displacement-controlled scheme to slide along the anterior-posterior (AP) direction on the tibial insert. At each time step, constraint force occurring at the articulating surface was derived from the reaction force at the distal fixation of the tibial baseplate. The force-displacement curve was plotted by combining the results of all time steps to characterize the constraint behavior of the prosthesis. A nonlinear FEA solver (NX Nastran SOL601, Siemens, TX, USA) was used to solve the simulation. In addition, five samples of the prostheses were physically tested per ASTM F1223. Simulation results were compared to the physical testing. Results. The simulation successfully captured the movement of contact location and pressure along the movement of the femoral component. The force-displacement curve predicted by the simulation exhibited a very close hysteresis loop profile as the results of physical testing. Using the curve slope from 0 to 5 mm to characterise the constraint in the most relevant displacement range, the simulation predicted 45.7 N/mm anteriorly and 36.4 N/mm posteriorly, which are less than 10% different from the physical testing results (46.4 N/mm anteriorly and 39.6 N/mm posteriorly). Discussion/Conclusion. This study demonstrated that the simulation was able to closely predict the femorotibial constraint behavior of the TKA prosthesis under ASTM F1223 testing. The simulation results resembled the physical test results not only in the general profile of the curve but also in the magnitude of slope values. The increased difference at the far anterior region could be related to the fact that no material nonlinearity was considered in the current simulation, a factor that could be improved in future studies. A validated simulation method could be very useful in TKA prosthesis design. Since no physical prototypes are required, design evaluation and optimization can be achieved in a much easier and faster manner

The surgical treatment options for patients who have sustained an intra-capsular hip fracture can vary depending on a number of patient and fracture related factors. Currently most national guidelines support the use of cemented prostheses for patient undergoing hemiarthroplasty surgery. Uncemented prostheses are commonly used for a variety of indications including those patients who have significant medical co-morbidities. To determine whether cemented hemiarthroplasty is associated with a higher post operative mortality when compared to uncemented procedures. Data were extracted from the Scottish SMR01 database from 01/04/1997 from all patients who were admitted to hospital after sustaining a hip fracture. We investigated mortality at day 1,2,4,7,30, 120 and 1 year from surgery vs. that on day 0. In order to control for the effects of confounding variables between patients cohorts, 12 case-mix variable were used to construct a multivariable logistic regression analysis model to determine the independent effect of prosthesis design. There were 52283 patients included in the study. Mortality for osteosynthesis of extra-capsular fractures was consistently lower when compared to that for surgical procedures for intra-capsular fractures. At day 0, uncemented hemiarthroplasty had a lower associated mortality (p<0.001) when compared to cemented implant designs. However, this increased mortality was equal to 1 extra death per 2000 procedures. From day 1 onward mortality for cemented procedures was equal to or lower than that of uncemented. By day 4, cumulative mortality was less for cemented than for uncemented procedures. Complication and re-operation rate was significantly higher in the uncemented cohort. The use of uncemented hemiarthroplasty for the treatment of intra-capsular hip fractures cannot be justified in terms of early/late post-operative mortality

In vitro the introduction of microseparation and edge loading to hip simulator gait cycle has replicated clinically relevant wear rates and wear mechanisms in ceramic-on-ceramic bearings. [1]. , and elevated the wear rates of MoM surface replacements (SR) to levels similar to those observed in retrievals. [2]. The aim was to assess the wear of two different sized MoM total hip replacement bearings under steep cup inclination angles and adverse microseparation and edge loading conditions. Two tests were performed on the Leeds II hip joint simulator using two different size bearings (28mm and 36mm). Cups were mounted to provide inclination angles of 45 degrees (n=3) and 65 degrees (n=3). The first three million cycles were under standard gait conditions. Microseparation and edge loading conditions as described by Nevelos et al. [1]. were introduced to the gait cycle for the subsequent three million cycles. The lubricant was 25% new born calf serum. The mean wear rates and 95% confidence limits were determined and statistical analysis was performed using One Way ANOVA. Under standard gait conditions, when the cup inclination angle increased from 45 degrees to 65 degrees, the wear of size 28mm bearing significantly (p=0.004) increased by 2.7-fold, however, the larger bearings did not show any increase in wear (p=0.9). The introduction of microseparation conditions resulted in a significant (p=0.0001) increase in wear rates for both bearing sizes under both cup inclination angle conditions. Under microseparation conditions, the increase in cup inclination angle had no influence on the wear rate for both bearing sizes (Figure 1). With larger bearings, head-rim contact occurs at a steeper cup inclination angle providing an advantage over smaller bearings. The introduction of edge loading and microseparation conditions resulted in a significant increase in wear rates for both bearing sizes. The wear rates obtained in this study under combined increased cup inclination angle and microseparation were half of those obtained when SR MoM bearings were tested under similar adverse conditions. [2]. This study shows the importance of prosthesis design and accurate surgical positioning of the head and acetabular cup in MoM THRs

Summary. Micromotions between stem and neck adapter depend on prosthesis design and material coupling. Based on the results of this study, the amount of micromotion seems to reflect the risk of fretting-induced fatigue in vivo. Introduction. Bimodular hip prostheses were developed to allow surgeons an individual reconstruction of the hip joint by varying length, offset and anteversion in the operation theatre. Despite these advantages, the use of these systems led to a high rate of postoperative complications resulting in revision rates of up to 11% ten years after surgical intervention. During daily activities taper connections of modular hip implants are highly stressed regions and contain the potential of micromotions between adjacent components, fretting and corrosion. This might explain why an elevated number of fretting-induced neck fractures occurred in clinics. However, some bi-modular prostheses (e.g. Metha, Aesculap, Ti-Ti) are more often affected by those complications than others (e.g. H-Max M, Limacorporate, Ti-Ti or Metha, Ti-CoCr) implying that the design and the material coupling have an impact on this failure pattern. Therefore, the purpose of this study was to clarify whether clinical successful prostheses offer lower micromotions than those with an elevated number of in vivo fractures. Materials and Methods. Two different bimodular hip designs (Metha and H-Max M, n = 6 each) were tested in vitro. Embedded Ti6Al4V (Ti) stems were assembled with Ti or CoCr29Mo (CoCr) necks and sinusoidally loaded (f = 1 Hz, 10,000 cycles) ranging from 0.23 to 4.30 kN (peak to peak, represents going upstairs) using a servohydraulic testing machine (MiniBionix II, MTS). Based on the results of four eddy-current sensors, micromotions were assessed in the region of the crack origin of fractured prostheses (lateral radius). Due to the test set-up, the recorded displacement includes, beside the real micromotions, the elastic deformation between sensor holder and reflector. The amount of the elastic deformation was determined using the finite-element technique. For statistical analyses Twoway-ANOVAs were performed (α = 0.05). Results. The H-Max M prostheses exhibited significantly lower micromotions compared to Metha prostheses (1.8 ± 2.2 µm vs. 4.1 ± 3.2 µm, p = 0.03). For Ti-Ti couplings, Metha prostheses showed a trend towards higher micromotions compared to H-Max M (6.5 ± 1.6 µm vs. 3.6 ± 1.5 µm, p = 0.08). Independent of the design, prostheses with Ti neck adapters caused significantly higher micromotions than those with CoCr adapters (5.1 ± 2.1 µm vs. 0.8 ± 1.6 µm, p < 0.01). No differences between the clinically used Metha prostheses with CoCr neck adapters and H-Max M prostheses with Ti necks were found (2.6 ± 2.0 µm, p = 0.25). Discussion. Both, the material coupling and the design influence the interface micromotions. The magnitude of micromotions might explain why bimodular hip systems are susceptible to fretting-induced fractures; however, the threshold for critical micromotions is still not known. The results of this study indicate that the amount of micromotion at taper interfaces could be directly linked to the risk of clinical failure

When performing the Scandinavian Total Ankle Replacement (STAR), the positioning of the talar component and the selection of mobile-bearing thickness are critical. A biomechanical experiment was undertaken to establish the effects of these variables on the range of movement (ROM) of the ankle.

Six cadaver ankles containing a specially-modified STAR prosthesis were subjected to ROM determination, under weight-bearing conditions, while monitoring the strain in the peri-ankle ligaments. Each specimen was tested with the talar component positions in neutral, as well as 3 and 6 mm of anterior and posterior displacement. The sequence was repeated with an anatomical bearing thickness, as well as at 2 mm reduced and increased thicknesses. The movement limits were defined as 10% strain in any ligament, bearing lift-off from the talar component or limitations of the hardware.

Both anterior talar component displacement and bearing thickness reduction caused a decrease in plantar flexion, which was associated with bearing lift-off. With increased bearing thickness, posterior displacement of the talar component decreased plantar flexion, whereas anterior displacement decreased dorsiflexion.