Introduction. With the development of 3D printing technology, there are many different types of PSI in the world. The accuracy of patient specific instrumentation (PSI) in primary total knee arthroplasty (TKA) is dependent on appropriate placement of the cutting blocks. However, previous reports on one type of PSI measured the difference between postoperative prosthetic alignment and postoperative mechanical axis and thus these reports did not evaluate intraoperative comparison of PSIs between two different designs. The purpose of this study was to evaluate the intraoperative accuracy of two different designed PSIs (My knee, Medacta International, Castel San Pietro, Switzerland) with two examiners using CT free navigation system (Stryker, Mahwar, NJ, USA) in regards to sagittal and coronal alignment. Methods. We enrolled 78knees (66 patients) with a primary cemented TKA using two different designed CT-based PSIs (My knee, Medacta International, Castel San Pietro, Switzerland). All operations were performed by two senior surgeons who have experience with greater than 500 TKAs and greater than 200 navigated TKAs. Two examiners were same two surgeons. The study period was between June 2015 and November 2016. The local ethics' committee approved the study prior to its initiation, and informed consent was obtained from all patients. After placement of the PSI on the femur and tibia, the position of the PSI was evaluated by s intraoperative navigation. Two examiners placed two different types (STD(standard) and MIS(minimum invasive surgery)) of PSI on same joint. As required by the PSI, only soft- tissue was removed and osteophytes were left in place. Femoral MIS PSI was required partial remove of lateral cartilage. For the femur, the coronal position in relation to the mechanical axis were documented. For the tibia, the coronal alignment and the tibial slope were documented. Of note, intraoperative modifications to the PSI were not made based upon the results of the navigation. Rather, the findings of the intraoperative navigation were simply documented. Results. The mean age of the cohort was 72.9±7.5years (range, 55–85years). The study included 11men and 55women, with a mean height of 151±8.2cm (range, 135–175cm), mean weight of 59.4±4.3kg (range, 42–82kg), and a mean of Body Mass Index of 25.9±3.6 (range, 17.2–36.4). HKA angle (supine position) measured by CT was 170.8 ±4.4 degree(range, 162.5–182degree). Diagnosis was osteoarthritis in all patient. There was no statistically significant difference in PSI position alignment for femoral flexion, tibial coronal angle, tibial slope between the two groups with two examiners. However, the intraoperative coronal position using the femoral STD PSI significantly deviated from using femoral MIS PSI from both examiners. (PSI vs. MIS, examiner1 p = 0.02, examiner2 p=0.04)

Summary Statement. A prospective randomised evaluation of primary TKA utilizing patient specific instruments demonstrated great accuracy of bone resection, improved sagittal alignment and the potential to improve functional outcomes and reduce operating room costs when compared to standard TKA instrumentation. Introduction. Patient specific instruments (PSI), an alternative to standard total knee arthroplasty (TKA) technology, have been proposed to improve the accuracy of TKA implant placement and post-operative limb alignment. Previous studies have shown mixed results regarding the effectiveness of PSI. The purposes of this study were (1) to evaluate the accuracy of the pre-operative predicted PSI plan compared to intra-operative TKA resection measurements, (2) to compare patient-reported outcome measures of PSI and standard TKA patients, and (3) to compare the incremental cost savings with PSI. Patients and Methods. This randomised, prospective pilot study of 19 patients undergoing primary TKA with a cruciate-retaining cemented prosthesis (NexGen, Zimmer Inc.) was conducted by a single high-volume arthroplasty surgeon (DCA). Patients were randomised to PSI or standard instrumentation. Patients randomised to the PSI cohort received a pre-operative knee MRI for PSI fabrication using Zimmer proprietary software. 10 standard TKA and 9 PSI TKA were completed. Pre-operative baseline SF-36 and WOMAC scores were collected. Operative data collected included operating room times, implant details, femoral (medial/lateral distal and posterior) and tibial (medial/lateral) cut thicknesses, and number of instrument trays used. Hospitalization data collected included length of stay, blood loss, drain output, and transfusion requirements. Follow-up occurred at 2 weeks, 6–8 weeks, 3 months, 6 months, and 1 year, with SF-36 and WOMAC scores collected at each time point. Routine radiographic analysis was carried out in both cohorts. Extensive financial data was collected including costs of operating room use and anesthesia, implants, and hospitalization. Statistical analyses included t-tests for continuous variables and chi-square tests for categorical variables. Results. All femoral and tibial implant sizes used during TKA matched the component sizes predicted by the PSI software. Flexion gap bone resection (posterior medial/lateral femoral cuts) was extremely accurate (<1 mm on average) when compared with PSI predictions. PSI proximal tibial bone resection was also extremely accurate and within 1 mm on average of predicted values. Sagittal plane tibial component posterior slope in PSI TKA was significantly more accurate (7.33 degrees) in comparison to standard instrumentation (4.20 degrees) (p<0.025). No significant differences in coronal mechanical limb alignment existed between the two cohorts (p>0.05). There were no differences in operating room times, length of stay, or transfusions between the two groups. PSI patients used 4 fewer instrument trays per case (p<0.0001). There were no significant differences in functional outcome scores between the two groups (p>0.05). Discussion/Conclusion. PSI TKA demonstrated outstanding accuracy in bone resection when compared with the custom operative plan. There was no difference in post-operative coronal limb alignment or individual component alignment between the two groups, but an improvement in tibial component alignment in the sagittal plane in the PSI cohort was statistically significant. The number of instrument trays in PSI TKA's were significantly less than standard TKA which led to less cost for instrument sterilization and assembly, and quicker room set-up. PSI instrumentation resulted in accurate bone resection and appropriate limb and component alignment after primary TKA in this prospective randomised evaluation

The aim of this project is to test the parameters of Patient Specific Instruments (PSIs) and measuring accuracy of surgical cuts using sawblades with different depths of PSI cutting guide slot. Clear operative oncological margins are the main target in malignant bone tumour resections. Novel techniques like patient specific instruments (PSIs) are becoming more popular in orthopaedic oncology surgeries and arthroplasty in general with studies suggesting improved accuracy and reduced operating time using PSIs compared to conventional techniques and computer assisted surgery. Improved accuracy would allow preservation of more natural bone of patients with smaller tumour margin. Novel low-cost technology improving accuracy of surgical cuts, would facilitate highly delicate surgeries such as Joint Preserving Surgery (JPS) that improves quality of life for patients by preserving the tibial plateau and muscle attachments around the knee whilst removing bone tumours with adequate tumour margins. There are no universal guidelines on PSI designs and there are no studies showing how specific design of PSIs would affect accuracy of the surgical cuts. We hypothesised if an increased depth of the cutting slot guide for sawblades on the PSI would improve accuracy of cuts. A pilot drybone experiment was set up, testing 3 different designs of a PSI with changing cutting slot depth, simulating removal of a tumour on the proximal tibia. A handheld 3D scanner (Artec Spider, Luxembourg) was used to scan tibia drybones and Computer Aided Design (CAD) software was used to simulate osteosarcoma position and plan intentioned cuts. PSI were designed accordingly to allow sufficient tumour. The only change for the 3 designs is the cutting slot depth (10mm, 15mm & 20mm). 7 orthopaedic surgeons were recruited to participate and perform JPS on the drybones using each design 2 times. Each fragment was then scanned with the 3D scanner and were then matched onto the reference tibia with customized software to calculate how each cut (inferior-superior-vertical) deviated from plan in millimetres and degrees. In order to tackle PSI placement error, a dedicated 3D-printed mould was used. Comparing actual cuts to planned cuts, changing the height of the cutting slot guide on the designed PSI did not deviate accuracy enough to interfere with a tumour resection margin set to maximum 10mm. We have obtained very accurate cuts with the mean deviations(error) for the 3 different designs were: [10mm slot: 0.76 ± 0.52mm, 2.37 ± 1.26°], [15 mm slot: 0.43 ± 0.40 mm, 1.89 ± 1.04°] and [20 mm: 0.74 ± 0.65 mm, 2.40 ± 1.78°] respectively, with no significant difference between mean error for each design overall, but the inferior cuts deviation in mm did show to be more precise with 15 mm cutting slot (p<0.05). Simulating a cut to resect an osteosarcoma, none of the proposed designs introduced error that would interfere with the tumour margin set. Though 15mm showed increased precision on only one parameter, we concluded that 10mm cutting slot would be sufficient for the accuracy needed for this specific surgical intervention. Future work would include comparing PSI slot depth with position of knee implants after arthroplasty, and how optimisation of other design parameters of PSIs can continue to improve accuracy of orthopaedic surgery and allow increase of bone and joint preservation

To characterize the microstructural organization of collagen fibers in human medial menisci and the response to mechanical loading in relation to age. We combine high resolution imaging with mechanical compression to visualize the altered response of the tissue at the microscale. Menisci distribute the load in the knee and are predominantly composed of water and specifically hierarchically arranged collagen fibers. Structural and compositional changes are known to occur in the meniscus during aging and development of osteoarthritis. However, how microstructural changes due to degeneration affect mechanical performance is still largely unknown [1]. Fresh frozen 4 mm Ø plugs of human medial menisci (n=15, men, 20-85 years) with no macroscopic damage nor known diseases from the MENIX biobank at Skåne University Hospital were imaged by phase contrast synchrotron tomography at the TOMCAT beamline (Paul Scherrer Institute, CH). A rheometer was implemented into the beamline to perform in-situ stress relaxation (2 steps 15% and 30% strain) during imaging (21 keV, 2.75μm pixel size). 40s scans were acquired before and after loading, while 14 fast tomographs (5s acquisitions) were taken during relaxation. The fiber 3D orientations and structural changes during loading were determined using a structure tensor approach (adapting a script from [1]). The 3D collagen fiber orientation in menisci revealed alternating layers of fibers. Two main areas are shown: surfaces and bulk. The surface layers are a mesh of randomly oriented fibers. Within the bulk 2-3 layers of fibers are visible that alternate about 30° to each other. Structural degeneration with age is visible and is currently being quantified. During stress-relaxation all menisci show a similar behavior, with samples from older donors being characterized by larger standard deviation Furthermore, the behavior of the different layers of fibers is tracked during relaxation showing how fibers with different orientation respond to the applied loading. Acknowledgments: We thank PSI for the beamtime at the TOMCAT beamline X02DA, and funding from Swedish Research Council (2019-00953), under the frame of ERA PerMed, and the Novo Nordisk Foundation through MathKOA (NNF21OC0065373)

Paediatric musculoskeletal (MSK) disorders often produce severe limb deformities, that may require surgical correction. This may be challenging, especially in case of multiplanar, multifocal and/or multilevel deformities. The increasing implementation of novel technologies, such as virtual surgical planning (VSP), computer aided surgical simulation (CASS) and 3D-printing is rapidly gaining traction for a range of surgical applications in paediatric orthopaedics, allowing for extreme personalization and accuracy of the correction, by also reducing operative times and complications. However, prompt availability and accessible costs of this technology remain a concern. Here, we report our experience using an in-hospital low-cost desk workstation for VSP and rapid prototyping in the field of paediatric orthopaedic surgery. From April 2018 to September 2022 20 children presenting with congenital or post-traumatic deformities of the limbs requiring corrective osteotomies were included in the study. A conversion procedure was applied to transform the CT scan into a 3D model. The surgery was planned using the 3D generated model. The simulation consisted of a virtual process of correction of the alignment, rotation, lengthening of the bones and choosing the level, shape and direction of the osteotomies. We also simulated and calculated the size and position of hardware and customized massive allografts that were shaped in clean room at the hospital bone bank. Sterilizable 3D models and PSI were printed in high-temperature poly-lactic acid (HTPLA), using a low-cost 3D-printer. Twenty-three operations in twenty patients were performed by using VSP and CASS. The sites of correction were: leg (9 cases) hip (5 cases) elbow/forearm (5 cases) foot (5 cases) The 3D printed sterilizable models were used in 21 cases while HTPLA-PSI were used in five cases. customized massive bone allografts were implanted in 4 cases. No complications related to the use of 3D printed models or cutting guides within the surgical field were observed. Post-operative good or excellent radiographic correction was achieved in 21 cases. In conclusion, the application of VSP, CASS and 3D-printing technology can improve the surgical correction of complex limb deformities in children, helping the surgeon to identify the correct landmarks for the osteotomy, to achieve the desired degree of correction, accurately modelling and positioning hardware and bone grafts when required. The implementation of in-hospital low-cost desk workstations for VSP, CASS and 3D-Printing is an effective and cost-advantageous solution for facilitating the use of these technologies in daily clinical and surgical practice

In total knee replacement (TKR), neutral mechanical alignment (NMA) is targeted in prosthetic component implantation. A novel implantation approach, referred to as kinematic alignment (KA), has been recently proposed (Eckhoff et al. 2005). This is based on the pre-arthritic lower limb alignment which is reconstructed using suitable image-based techniques, and is claimed to allow better soft-tissue balance (Eckhoff et al. 2005) and restoration of physiological joint function. Patient-specific instrumentation (PSI) introduced in TKR to execute personalized prosthesis component implantation are used for KA. The aim of this study was to report knee kinematics and electromyography (EMG) for a number lower limb muscles from two TKR patient groups, i.e. operated according to NMA via conventional instrumentation, or according to KA via PSI. 20 patients affected by primary gonarthrosis were implanted with a cruciate-retaining fixed-bearing prosthesis with patella resurfacing (Triathlon® by Stryker®, Kalamazoo, MI-USA). 17 of these patients, i.e. 11 operated targeting NMA (group A) via convention instrumentation and 6 targeting KA (group B) via PSI (ShapeMatch® by Stryker®, Kalamazoo, MI-USA), were assessed clinically using the International Knee Society Scoring (IKSS) System and biomechanically at 6-month follow-up. Knee kinematics during stair-climbing, chair-rising and extension-against-gravity was analysed by means of 3D video-fluoroscopy (CAT® Medical System, Monterotondo, Italy) synchronized with 4-channel EMG analysis (EMG Mate, Cometa®, Milan, Italy) of the main knee ad/abductor and flexor/extensor muscles. Knee joint motion was calculated in terms of flex/extension (FE), ad/abduction (AA), and internal/external rotation (IE), together with axial rotation of condyle contact point line (CLR). Postoperative knee and functional IKSS scores in group A were 78±20 and 80±23, worse than in group B, respectively 91±12 and 90±15. Knee motion patterns were much more consistent over patients in group B than A. In both groups, normal ranges were found for FE, IE and AA, the latter being generally smaller than 3°. Average IE ranges in the three motor tasks were respectively 8.2°±3.2°, 10.1°±3.9° and 7.9°±4.0° in group A, and 6.6°±4.0°, 10.5°±2.5° and 11.0°±3.9° in group B. Relevant CLRs were 8.2°±3.2°, 10.2°±3.7° and 8.8°±5.3° in group A, and 7.3°±3.5°, 12.6°±2.6° and 12.5°±4.2° in group B. EMG analysis revealed prolonged activation of the medial/lateral vasti muscles in group A. Such muscle co-contraction was not generally observed in all patients in group B, this perhaps proving more stability in the knee replaced following the KA approach. These results reveal that KA results in better function than NMA in TKR. Though small differences were observed between groups, the higher data consistency and the less prolonged muscle activations detected using KA support indirectly the claim of a more natural knee soft tissue balance. References

Orbital floor (OF) fractures are commonly treated by implanting either bioinert titanium or polyethylene implants, or by autologous grafts. A personalized implant made of biodegradable and osteopromotive poly(trimethylene carbonate) loaded with hydroxyapatite (PTMC-HA) could be a suitable alternative for patients where a permanent implant could be detrimental. A workflow was developed from the implant production using stereolithography (SLA) based on patient CT scan to the implantation and assessment its performance (i.e. implant stability, orbit position, bone formation) compared to personalised titanium implants in a repair OF defect sheep model. Implants fabrication was done using SLA of photo-crosslinkable PTMC mixed with HA [1–3]. Preclinical study: (sheep n=12, ethic number 34_2016) was conducted by first scanning the OF bone of each sheep in order to design and to fabricate patient specific implants (PSI) made of PTMC-HA. The fabricated PSI was implanted after creating OF defect. Bone formation and defect healing was compared to manually shaped titanium mesh using time-laps X-ray analyses, histology (Giemsa-Eosin staining) and sequential fluorochrome staining over 3-months. Additionally, the osteoinductive property of the biomaterials was assessed by intramuscular implantation (IM). In this study, we showed that the composite PTMC-HA allowed for ectopic bone formation after IM implantation, without requiring any biotherapeutics. In addition, we could repair OF defect on sheep using SLA-fabricated PTMC-HA with a good shape fidelity (compared to the virtual implant) and a better bone integration compared to the titanium mesh. This study opens the field of patient-specific implants made of degradable and osteoinductive scaffolds fabricated using additive manufacturing to replace advantageously autologous bone and titanium implants

Total knee replacements (TKR) have been the main choice of treatment for alleviating pain and restoring physical function in advanced degenerative osteoarthritis of the knee. Recently, there has been a rising interest in minimally invasive surgery TKR (MIS-TKR). However, accurate restoration of the knee axis presents a great challenge. Patient-specific-instrumented TKR (PSI-TKR) was thus developed to address the issue. However, the efficacy of this new approach has yet to be determined. The purpose of the current study was thus to measure and compare the 3D kinematics of the MIS-TKR and PSI-TKR in vivo during sit-to-stand using a 3D fluoroscopy technology. Five patients each with MIS-TKR and PSI-TKR participated in the current study with informed written consent. Each subject performed quiet standing to define their own neutral positions and then sit-to-stand while under the surveillance of a bi-planar fluoroscopy system (ALLURA XPER FD, Philips). For the determination of the 3D TKR kinematics, the computer-aided design (CAD) model of the TKR for each subject was obtained from the manufacturer including femoral and tibial components and the plastic insert. At each image frame, the CAD model was registered to the fluoroscopy image via a validated 2D-to-3D registration method. The CAD model of each prosthesis component was embedded with a coordinate system with the origin at the mid-point of the femoral epicondyles, the z-axis directed to the right, the y-axis directed superiorly, and the x-axis directed anteriorly. From the accurately registered poses of the femoral and tibial components, the angles of the TKR were obtained following a z-x-y cardanic rotation sequence, corresponding to flexion/extension, adduction/abduction and internal/external rotation. During sit-to-stand the patterns and magnitudes of the translations were similar between the MIS-TKR and PSI-TKR groups, with posterior translations ranging from 10–20 mm and proximal translations from 29–31mm. Differences in mediolateral translations existed between the groups but the magnitudes were too small to be clinically significant. For angular kinematics, both groups showed close-to-zero abduction/adduction, but the PSI-TKR group rotated externally from an internally rotated position (10° of internal rotation) to the neutral position, while the MIS-TKR group maintained at an externally rotated position of less than 5° during the movement. During sit-to-stand both groups showed similar patterns and magnitudes in the translations but significant differences in the angular kinematics existed between the groups. While the MIS-TKR group maintained at an externally rotated position during the movement, the PSI-TKR group showed external rotations during knee extension, a pattern similar to the screw home mechanism in a normal knee, which may be related to more accurate restoration of the knee axis in the PSI-TKR group. A close-to-normal angular motion may be beneficial for maintaining a normal articular contact pattern, which is helpful for the endurance of the TKR. The current study was the first attempt to quantify the kinematic differences between PSI and non-PSI MIS. Further studies to include more subjects will be needed to confirm the current findings. More detailed analysis of the contact patterns is also needed

Objectives

Recent studies have shown that modulating inflammation-related lipid signalling after a bone fracture can accelerate healing in animal models. Specifically, decreasing 5-lipoxygenase (5-LO) activity during fracture healing increases cyclooxygenase-2 (COX-2) expression in the fracture callus, accelerates chondrogenesis and decreases healing time. In this study, we test the hypothesis that 5-LO inhibition will increase direct osteogenesis.

Malrotation of the femoral component is a cause of patellofemoral maltracking after total knee arthroplasty. Its precise effect on the patellofemoral mechanics has not been well quantified. We have developed an in vitro method to measure the influence of patellar maltracking on contact. Maltracking was induced by progressively rotating the femoral component either internally or externally. The contact mechanics were analysed using Tekscan. The results showed that excessive malrotation of the femoral component, both internally and externally, had a significant influence on the mechanics of contact. The contact area decreased with progressive maltracking, with a concomitant increase in contact pressure. The amount of contact area that carries more than the yield stress of ultra-high molecular weight polyethylene significantly increases with progressive maltracking. It is likely that the elevated pressures noted in malrotation could cause accelerated and excessive wear of the patellar button.