Summary Statement

In this study, excellent positioning of custom-made glenoid components was achieved using patient-specific guides. Achieving the preoperatively planned orientation of the component improved significantly and more screws were located inside the scapular bone compared to implantations without such guide.

In severe cases of total knee arthroplasty which cannot be treated with off-the-shelf implants anymore custom-made knee implants may serve as one of the few remaining options to restore joint function or to prevent limb amputation. Custom-made implants are specifically designed and manufactured for one individual patient in a single-unit production, in which the surgeon is responsible for the implant design characteristics in consultation with the corresponding engineer. The mechanical performance of these custom-made implants is challenging to evaluate due to the unique design characteristics and the limited time until which the implant is needed. Nevertheless, the custom-made implant must comply with clinical and regulatory requirements. The design of custom-made implants is often based on a underlying reference implant with available biomechanical test results and well-known clinical performance. To support surgeons and engineers in their decision whether a specific implant design is suitable, a method is proposed to evaluate its mechanical performance. The method uses finite element analysis (FEA) and comprises six steps: (1) Identification of the main potential failure mechanism and its corresponding FEA quantity of interest. (2) Reproduction of the biomechanical test of the reference implant via FEA. (3) Identification of the maximum value of the corresponding FEA quantity of interest at the required load level. (4) Definition of this value as the acceptance criteria for the FEA of the custom-made implant. (5) Reproduction of the biomechanical test with the custom-made implant via FEA. (6) Conclusion whether the acceptance criteria is fulfilled or not. The method was applied to two exemplary cases of custom-made knee implants. The FEA acceptance criteria derived from the reference implants were fulfilled in both custom-made implants. Subsequent biomechanical tests verified the FEA results. This study suggests and applies a non-destructive and efficient method for pre-clinical testing of a single-unit custom-made knee implant to evaluate whether the design is mechanically suitable

In severe cases of total knee & hip arthroplasty, where off-the-shelf implants are not suitable (i.e., in cases with extended bone defects or periprosthetic fractures), 3D-printed custom-made knee & hip revision implants out of titanium or cobalt-chromium alloy represent one of the few remaining clinical treatment options. Design verification and validation of such custom-made implants is very challenging. Therefore, a methodology was developed to support surgeons and engineers in their decision on whether a developed design is suitable for the specific case. A novel method for the pre-clinical testing of 3D-printed custom-made knee implants has been established, which relies on the biomechanical test and finite element analysis (FEA) of a comparable clinically established reference implant. The method comprises different steps, such as identification of the main potential failure mechanism, reproduction of the biomechanical test of the reference implant via FEA, identification of the maximum value of the corresponding FEA quantity of interest at the required load level, definition of this value as the acceptance criterion for the FEA of the custom-made implant, reproduction of the biomechanical test with the custom-made implant via FEA, decision making for realization or re-design based on the acceptance criterion is fulfilled or not. Exemplary cases of custom-made knee & hip implants were evaluated with this new methodology. The FEA acceptance criterion derived from the reference implants was fulfilled in both custom-made implants and subsequent biomechanical tests verified the FEA results. The suggested method allows a quantitative evaluation of the biomechanical properties of custom-made knee & hip implant without performing physical bench testing. This represents an important contribution to achieve a sustainable patient treatment in complex revision total knee & hip arthroplasty with custom-made 3D printed implants in a safe and timely manner

In the last years, 3d printing has progressively grown and it has reached a solid role in clinical practice. The main applications brought by 3d printing in orthopedic surgery are: preoperative planning, custom-made surgical guides, custom-made im- plants, surgical simulation, and bioprinting. The replica of the patient's anatomy, starting from the elaboration of medical volumetric images (CT, MRI, etc.), allows a progressive extremization of treatment personalization that could be tailored for every single patient. In complex cases, the generation of a 3d model of the patient's anatomy allows the surgeons to better understand the case — they can almost “touch the anatomy” —, to perform a more ac- curate preoperative planning and, in some cases, to perform device positioning before going to the surgical room (i.e. joint arthroplasty). 3d printing is also commonly used to produce surgical cutting guides, these guides are positioned intraoperatively on given landmarks to guide the surgeon to perform a specific surgical act (bone osteotomy, bone resection, implant position, etc.). In total knee arthroplasty, custom-made cutting guides have been developed to help the surgeon align the femoral and tibial components to the pre-arthritic condition with- out the use of the intramedullary femoral guide. 3d printed custom-made implants represent an emerging alternative to biological reconstructions especially after oncologic resection surgery or in case of complex arthroplasty revision surgery. Custom-made implants are designed to re- place the original shape and size of the patient's bone and they allow an extreme personalization of the treatment for every single patient. Patient-specific surgical simulation is a new frontier that promises great benefits for surgical training. a solid 3d model of the patient's anatomy can faithfully reproduce the surgical complexity of the patient and it allows to generate surgical simulators with increasing difficulty to adapt the difficulties of the course with the level of the trainees performing structured training paths: from the “simple” case to the “complex” case

Abstract. Background. Distal femoral osteotomy is an established successful procedure which can delay the progression of arthritis and the need for knee arthroplasty. The surgery, however, is complex and lengthy and consequently it is generally the preserve of highly experienced specialists and thus not widely offered. Patient specific instrumentation is known to reduce procedural complexity, time, and surgeons’ anxiety levels. 1. in proximal tibial osteotomy procedures. This study evaluated a novel patient specific distal femoral osteotomy procedure (Orthoscape, Bath, UK) which aimed to use custom-made implants and instrumentation to provide a precision correction while also simplifying the procedure so that more surgeons would be comfortable offering the procedure. Presenting problem. Three patients (n=3) with early-stage knee arthritis presented with valgus malalignment, the source of which was predominantly located within the distal femur, rather than intraarticular. Using conventional techniques and instrumentation, distal femoral knee osteotomy cases typically require 1.5–2 hours surgery time. The use of bi-planar osteotomy cuts have been shown to improve intraoperative stability as well as bone healing times. 2. This normally also increases surgical complexity; however, multiple cutting slots can be easily incorporated into patient specific instrumentation. Clinical management. All three cases were treated at a high-volume tertiary referral centre (Istituto Ortopedico Rizzoli, Bologna) using medial closing wedge distal femoral knee osteotomies by a team experienced in using patient specific osteotomy systems. 3. Virtual surgical planning was conducted using CT-scans and long-leg weight-bearing x-rays (Orthoscape, Bath, UK). Patient specific surgical guides and custom-made locking plates were design for each case. The guides were designed to allow temporary positioning, drilling and bi-planar saw-cutting. The drills were positioned such that the drills above and below the osteotomy became parallel on closing following osteotomy wedge removal. This gave reassurance of the achieved correction allowed the plate to be located precisely over the drills. All screw lengths were pre-measured. Discussion. The surgical time reduced to approximately 30 minutes by the third procedure. It was evident that surgical time was saved because no intraoperative screw length measurements were required, relatively few x-rays were used to confirm the position of the surgical guide, and the use of custom instrumentation significantly reduced the surgical inventory. The reduced invasiveness and ease of surgery may contribute to faster patient recovery compared to conventional techniques. The final post-operative alignment was within 1° of the planned alignment in all cases. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

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

Objectives

Healing in cancellous metaphyseal bone might be different from midshaft fracture healing due to different access to mesenchymal stem cells, and because metaphyseal bone often heals without a cartilaginous phase. Inflammation plays an important role in the healing of a shaft fracture, but if metaphyseal injury is different, it is important to clarify if the role of inflammation is also different. The biology of fracture healing is also influenced by the degree of mechanical stability. It is unclear if inflammation interacts with stability-related factors.

We implanted titanium and carbon fibre-reinforced plastic (CFRP) femoral prostheses of the same dimensions into five prosthetic femora. An abductor jig was attached and a 1 kN load applied. This was repeated with five control femora. Digital image correlation was used to give a detailed two-dimensional strain map of the medial cortex of the proximal femur. Both implants caused stress shielding around the calcar. Distally, the titanium implant showed stress shielding, whereas the CFRP prosthesis did not produce a strain pattern which was statistically different from the controls. There was a reduction in strain beyond the tip of both the implants.

This investigation indicates that use of the CFRP stem should avoid stress shielding in total hip replacement.