Despite past advances of implant technologies, complication rates of fixations remain high at challenging sites such as the proximal humerus [1]. These may not only be owed to the implant itself but also to dissatisfactory surgical execution of fracture reduction and implant positioning. Therefore, the aim of this study was to quantify the instrumentation accuracy of a highly standardised and guided procedure and its influence on the biomechanical outcome and predicted failure risk. Preoperative planning of osteotomies creating an unstable 3-part fracture and fixation with a locking plate was performed based on CT scans of eight pairs of low-density proximal humerus samples from elderly female donors (85.2±5.4 years). 3D-printed subject-specific guides were used to osteotomise and instrument the samples according to the pre-OP plan. Instrumentation accuracies in terms of screw lengths and orientations were evaluated by comparing post-OP CT scans with the pre-OP plan. The fixation constructs were biomechanically tested until cyclic cut-out failure [2]. Failure risks of the planned and the post-OP configurations were predicted using a validated sample-specific finite element (FE) simulation approach [2] and correlated with the experimental outcomes. Small deviations were found for the instrumented screw trajectories compared to the planned configuration in the proximal-distal (0.3±1.3º) and anterior-posterior directions (-1.7±1.8º), and for screw tip to joint distances (-0.3±1.1 mm). Significantly higher failure risk was predicted for the post-OP compared to the planned configurations (p<0.01) via FE. When incorporating the instrumentation inaccuracies, the biomechanical results could be predicted well with FE (R. 2. =0.70). Despite the high instrumentation accuracy achieved using sophisticated subject-specific 3D-printed guides, even minor deviations from the pre-OP plan significantly increased the FE-predicted risk of failure. This underlines the importance of intraoperative guiding technology [3] in tandem with careful pre-OP planning to assist surgeons to achieve optimal outcomes. Acknowledgements. This study was performed with the assistance of the AO Foundation via the AOTRAUMA Network

The aim of this study was to report the restauration of the normal vertebral morphology and the absence of curve progression after removal the instrumentation in AIS patients that underwent posterior correction of the deformity by common all screws construct whitout fusion. A series of 36 AIS immature patients (Risser 3 or less) were include in the study. Instrumentation was removed once the maturity stage was complete (Risser 5). Curve correction was assessed at pre and postoperative, before instrumentation removal, just post removal, and more than two years after instrumentation removal. Epiphyseal vertebral growth modulation was assessed by a coronal wedging ratio (WR) at the apical level of the main curve (MC). The mean preoperative coronal Cobb was corrected from 53.7°±7.5 to 5.5º±7.5º (89.7%) at the immediate postop. After implants removal (31.0±5.8 months) the MC was 13.1º. T5–T12 kyphosis showed a significant improvement from 19.0º before curve correction to 27.1º after implants removal (p<0.05). Before surgery, WR was 0.71±0.06, and after removal WR was 0.98±0.08 (p<0.001). At the end of follow-up, the mean sagittal range of motion (ROM) of the T12-S1 segment was 51.2±21.0º. SRS-22 scores improved from 3.31±0.25 preoperatively to 3.68±0.25 at final assessment (p<0.001). In conclusion, fusionless posterior approach using a common all pedicle screws construct correct satisfactory scoliotic main curves and permits removal of the instrumentation once the bone maturity is reached. The final correction was highly satisfactory and an acceptable ROM of the previously lower instrumented segments was observed

Introduction. In daily clinical practice, progression of spinal fusion is typically monitored during clinical follow-up using conventional radiography and Computed Tomography scans. However, recent research has demonstrated the potential of implant load monitoring to assess posterolateral spinal fusion in an in-vivo sheep model. The question arises to whether such a strain sensing system could be used to monitor bone fusion following lumbar interbody fusion surgery, where the intervertebral space is supported by a cage. Therefore, the aim of this study was to test human cadaveric lumbar spines in two states: after a transforaminal lumbar interbody fusion (TLIF) procedure combined with a pedicle-screw-rod-construct (PSR) and subsequently after simulating bone fusion. The study hypothesized that the load on the posterior instrumentation decreases as the segment stiffens due to simulated fusion. Method. A TLIF procedure with PSR was performed on eight human cadaveric spines at level L4-L5. Strain sensors were attached bilaterally to the rods to derive implant load changes during unconstrained flexion-extension (FE), lateral bending (LB) and axial rotation (AR) loads up to ±7.5Nm. The specimens were retested after simulating bone fusion between vertebrae L4-L5. In addition, the range of motion (ROM) was measured during each loading mode. Result. The ROM decreased in the simulated bone fusion state in all loading directions (p≤0.002). In both states, the measured strain on the posterior instrumentation was highest during LB motion. Furthermore, the sensors detected a significant decrease in the load induced rod strain (p≤0.002) between TLIF+PSR and simulated bone fusion state in LB. Conclusion. Implant load measured via rod strain sensors can be used to monitor the progression of fusion after a TLIF procedure when measured during LB of the lumbar spine. However, further research is needed to investigate the influence of daily loading scenarios expected in-vivo on the overall change in implant load

The medial opening-wedge high tibial osteotomy (OW-HTO) is an accepted option to treat the isolated medial compartment osteoarthritis (OA) in varus knee. Despite satisfactory outcomes were described in literature, consistent complication rate has been reported and the provided accuracy of coronal alignment correction using conventional HTO techniques falls short. Patient specific instrumentations has been introduced with the aim to reduce complications and to improve the intra-operative accuracy according to the pre-operative plan, which is responsible for the clinical result of the surgery. In this talk, an overview of the clinical results of HTO patient specific instrumentation available in literature will be performed. Moreover, preliminary intra-operative and clinical results of a new customised 3-D printed cutting guide and fixation plate for OW-HTO will be presented

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

Introduction

Transosseous flexion-distraction injuries of the spine typically require surgical intervention by stabilizing the fractured vertebra during healing with a pedicle-screw-rod constructs. As healing is taking place the load shifts from the implant back to the spine. Monitoring the load-induced deflection of the rods over time would allow quantifiable postoperative assessment of healing progress without the need for radiation exposure or frequent hospital visits. This approach, previously demonstrated to be effective in assessing fracture healing in long bones and monitoring posterolateral spinal fusion in sheep, is now being investigated for its potential in evaluating lumbar vertebra transosseous fracture healing.

Summary. Pyogenic spondylodiscitis is an uncommon but severe spinal infection. In majority of cases treatment is based on intravenous antibiotics and rigid brace immobilization. Posterior percutaneous spinal instrumentation is a safe alternative procedure in relieving pain, preventing deformity and neurological compromise. Introduction. Pyogenic spondylodiscitis (PS) is an uncommon but severe spinal infection. Patients affected by a non-complicated PS and treatment is based on intravenous antibiotics and rigid brace immobilization with a thoracolumbosacral orthosis (TLSO) suffices in most cases in relieving pain, preventing deformity and neurological compromise. Since January 2010 we started offering patients percutaneous posterior screw-rod instrumentation as alternative approach to TLSO immobilization. The aim of this study was to evaluate safety and effectiveness of posterior percutaneous spinal instrumentation for single level lower thoracic (T9-T12) or lumbar pyogenic spondylodiscitis. Materials and Methods. Retrospective cohort analysis on 27 patients diagnosed with PS who were offered to choose between 24/7 TLSO rigid bracing for 3 to 4 months and posterior percutaneous screw-rod instrumentation bridging the infection level followed by soft bracing for 4 weeks after surgery. All patients underwent antibiotic therapy. Fifteen patients chose conservative treatment, 12 patients chose surgical treatment. Patients were seen at 1, 3, 6, 9 months after diagnosis. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and complete blood count were measured at each follow-up visit. Segmental kyphosis was measured at diagnosis and at 9 months. VAS, SF-12, and EQ-5D questionnaires were recorded at each follow-up visit. Baseline groups’ demographic characteristics were assessed using independent sample t-tests for continuous variables and χ2 tests for frequency variables. Results. Complete healing was achieved in all patients, no difference was observed in healing time between the two groups (77.3±7.2 days vs 80.2±4.4). Instrumentation failure and screw loosening was not observed in any patient. In both group CRP and ESR decreased accordingly with response to antibiotic therapy. Surgically treated patients had significantly lower VAS scores at 1 month (3.05±0.57 in surgery group vs 5.20±1.21 in TLSO group) and 3 months (2.31±0.54 in surgery group vs 2.85±0.55 in TLSO group) post-diagnosis. Both groups had similar trends toward fast recovery in both mental (MCS) and physical components (PCS) of SF-12 questionnaire, surgically treated patients showed steeper and statistically significative improvement at 1 month (37.83±4.57 MCS in surgery group vs 24.52±3.03 MCS in TLSO group and 35.46±4.43 PCS in surgery group vs 27.07±4.45 PCS in TLSO group, p<0.001), 3 months (52.94±3.82 MCS in surgery group vs 39.45±4.92 MCS in TLSO group and 44.93±3.73 PCS in surgery group vs 35.33±6.44 PCS in TLSO group, p<0.001), and 6 months (54.93±3.56 MCS in surgery group vs 49.99±5.82 MCS in TLSO group) post-diagnosis, no statistically significant differences were detected at the other time points (9 months post-diagnosis). EQ-5D index was significantly higher in surgery patients at 1 month (0.764±0.043 in surgery group vs 0.458±0.197 in TLSO group) and 3 months (0.890±0.116 in surgery group vs 0.688±0.142 in TLSO group); no statistically significant changes were observed in segmental kyphosis between the two groups. Conclusion. Posterior percutaneous spinal instrumentation is a safe, feasible, and effective procedure in relieving pain, preventing deformity and neurological compromise. Surgical stabilization was associated with faster recovery, lower pain scores, and improved quality of life compared with TLSO conservative treatment at 1 and 3 months after diagnosis

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. Alignment results did not differ between PSG and conventional instrumentation. A small reduction in operation time and blood loss was found with the PSG system, but is unlikely of clinical significance. Length of hospital stay was identical for both groups. Introduction. Several techniques for aligning a TKA exist nowadays. Patient-specific guiding (PSG) has relatively recently been introduced to try to resolve the shortcomings of existing techniques while optimising the operative procedure. Still few reports have been published on the clinical outcome and on the peroperative results of this new technique. This prospective, double-blind, randomised controlled trial was designed to address the following research questions: 1. Is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA. 2. Is there a significant difference in operation time, blood loss and length of hospital stay between the 2 techniques. Patients & Methods. 180 patients were randomised for PSG TKA (group 1) or conventional TKA (group 2) in 2 centres. Patients were stratified per hospital. Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital, standing, long-leg and standard lateral radiographs by 2 independent outcome assessors in both centres. Percentages of outliers, > 3°, were determined. We compared blood loss, operation time and length of hospital stay. Results. There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups. No statistically significant difference was found for the alignment of the individual components in the frontal plane, nor for the percentages of outliers. There was a statistically significant difference in outliers for the femoral component in the sagittal plane, with a higher percentage of outliers in the group 1 (p = 0.017). No such significant result was found for the tibial component in that plane. All interclass correlation coefficients were good. Blood loss was 100 mL less in group 1 (p = 0.000). Operation time was 5 minutes shorter in group 1 (p = 0.000). Length of hospital stay was almost identical with a mean of 3.6 days (p = 0.657). Discussion/Conclusions. The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups. A small reduction in operation time and blood loss was found with the PSG system, but is unlikely of any clinical significance. Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA

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.

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

Introduction. The biomechanical behavior of lumbar spine instrumentation is critical in understanding its efficacy and durability in clinical practice. In this study, we aim to compare the biomechanics of the lumbar spine instrumented with single-level posterior rod and screw systems employing two distinct screw designs: paddle screw versus conventional screw system. Method. A fully cadaveric-validated 3D ligamentous model of the lumbopelvic spine served as the foundation for our comparative biomechanical analysis. 1. To simulate instrumentation, the intact spine was modified at the L4L5 level, employing either paddle screws or standard pedicle screws (SPS). The implants were composed of Ti-6AL-4V. Fixation at the S1 ensured consistency across loading scenarios. Loading conditions included a 400-N compressive load combined with a 10 N.m pure bending moment at the level of L1, replicating physiological motions of flexion-extension, lateral bending and axial rotation. We extracted data across various scenarios, focusing on the segmental range of motion at both implanted and adjacent levels. Result. In the flexion of L4L5, the applied force ranged from -29.2 to 29.3 N in the paddle screw, while it ranged from -25 to 25 N in the PS system. Similarly, the extension of L4L5 ranged from -3.1 to 2.6 N in the paddle and ranged from -4.5 to 3.9 N in the SPS system. In terms of stress distributions on the screw, stress concentrations decreased in several cases in the paddle design compared to the SPS systems. Top of Form. Conclusion. The paddle screw enhanced the range of motion overall in both the upper adjacent segment (L3L4) and the lower adjacent segment (L5S1) compared to the conventional SPS system. The stability of the aimed segment was increased by 33% on average with the paddle screw compared to conventional PS. Increasing the stability of the host segment decreases the possibility of non-union and the rate of fusion failure . 2.

Introduction. Pedicle screw loosening in posterior instrumentation of thoracolumbar spine occurs up to 60% in osteoporotic patients. These complications may be alleviated using more flexible implant materials and novel designs that could be optimized with reliable computational modeling. This study aimed to develop and validate non-linear homogenized finite element (hFE) simulations to predict pedicle screw toggling. Method. Ten cadaveric vertebral bodies (L1-L5) from two female and three male elderly donors were scanned with high-resolution peripheral quantitative computed tomography (HR-pQCT, Scanco Medical) and instrumented with pedicle screws made of carbon fiber-reinforced polyether-etherketone (CF/PEEK). Sample-specific 3D-printed guides ensured standardized instrumentation, embedding, and loading procedures. The samples were biomechanically tested to failure in a toggling setup using an electrodynamic testing machine (Acumen, MTS) applying a quasi-static cyclic testing protocol of three ramps with exponentially increasing peak (1, 2 and 4 mm) and constant valley displacements. Implant-bone kinematics were assessed with a stereographic 3D motion tracking camera system (Aramis SRX, GOM). hFE models with non-linear, homogenized bone material properties including a strain-based damage criterion were developed based on intact HR-pQCT and instrumented 3D C-arm scans. The experimental loading conditions were imposed, the maximum load per cycle was calculated and compared to the experimental results. HR-pQCT-based bone volume fraction (BV/TV) around the screws was correlated with the experimental peak forces at each displacement level. Result. The nonlinear hFE models accurately (slope = 1.07, intercept = 0.2 N) and precisely (R. 2. = 0.84) predicted the experimental peak forces at each displacement level. BV/TV alone was a weak predictor (R. 2. <0.31). Conclusion. The hFE models enable fast design iterations aiming to reduce the risk of screw loosening in low-density vertebrae. Improved flexible implant designs are expected to contribute to reduced complication rates in osteoporotic patients

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

Abstract. Objectives. High tibial osteotomy for knee realignment is effective at relieving symptoms of knee osteoarthritis but the operation is surgically challenging. A new personalised treatment with simpler surgery using pre-operatively planned measurements from computed tomography (CT) imaging and 3D-printed implants and instrumentation has been designed and is undergoing clinical trial. The aim of this study was to evaluate the early clinical results of a preliminary pilot study evaluating the safety of this new personalised treatment. Methods. The single-centre prospective clinical trial is ongoing (IRCCS Istituto Ortopedico Rizzoli; IRB-0013355; ClinicalTrials.gov NCT04574570), with recruitment completed and all patients having received the novel custom surgical treatment. To preserve the completeness of the trial reporting, only surgical aspects were evaluated in the present study. Specifically, the length of the implanted osteosynthesis screws was considered, being determined pre-operatively eliminating intraoperative measurements, and examined post-operatively (n=7) using CT image processing (ScanIP, Synopsys) and surface distance mapping. The surgical time, patient discharge date and ease of wound closure were recorded for all patients (n=25). Results. Over the study period the average surgical time (skin incision to suture) reduced from 54 to 31 minutes (range: 17–62, n=25). It was noted that wound closure was easier than the conventional surgery due to the lower profile of the implant. Over seventy percent of patients were discharged day 2 post-op. The position, orientation and length of all screws matched the pre-operative configuration to within approximately 1mm. Conclusions. The early trial results are promising from a clinical perspective. It was evident that surgical time was saved because no intraoperative screw length measurements were required, 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 full trial results will be reported later this year. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

High tibial osteotomy (HTO) is an effective surgical treatment for isolated medial compartment knee osteoarthritis; however, widespread adoption is limited due to difficulty in achieving the planned correction, and patient dissatisfaction due to soft tissue irritation. A new HTO system – Tailored Osteotomy Knee Alignment (TOKA®, 3D Metal Printing Ltd, Bath, UK) could potentially address these barriers having a custom titanium plate and titanium surgical guides featuring a unique mechanism for precise osteotomy opening as well as saw cutting and drilling guides. The aim of this study was to assess the accuracy of this novel HTO system using cadaveric specimens; a preclinical testing stage ahead of first-in-human surgery according to the ‘IDEAL-D’ framework for device innovation. Local ethics committee approval was obtained. The novel opening wedge HTO procedure was performed on eight cadaver leg specimens. Whole lower limb CT scans pre- and post-operatively provided geometrical assessment quantifying the discrepancy between pre-planned and post-operative measurements for key variables: the gap opening angle and the patient specific surgical instrumentation positioning and rotation - assessed using the implanted plate. The average discrepancy between the pre-operative plan and the post-operative osteotomy correction angle was: 0.0 ± 0.2°. The R2 value for the regression correlation was 0.95. The average error in implant positioning was −0.4 ± 4.3 mm, −2.6 ± 3.4 mm and 3.1 ± 1.7° vertically, horizontally, and rotationally respectively. This novel HTO surgery has greater accuracy and smaller variability in correction angle achieved compared to that reported for conventional or other patient specific methods with published data available. This system could potentially improve the accuracy and reliability of osteotomy correction angles achieved surgically

Gait analysis is an indispensable tool for scientific assessment and treatment of individuals whose ability to walk is impaired. The high cost of installation and operation are a major limitation for wide-spread use in clinical routine. Advances in Artificial Intelligence (AI) could significantly reduce the required instrumentation. A mobile phone could be all equipment necessary for 3D gait analysis. MediaPipe Pose provided by Google Research is such a Machine Learning approach for human body tracking from monocular RGB video frames that is detecting 3D-landmarks of the human body. Aim of this study was to analyze the accuracy of gait phase detection based on the joint landmarks identified by the AI system. Motion data from 10 healthy volunteers walking on a treadmill with a fixed speed of 4.5km/h (Callis, Sprintex, Germany) was sampled with a mobile phone (iPhone SE 2nd Generation, Apple). The video was processed with Mediapipe Pose (Version 0.9.1.0) using custom python software. Gait phases (Initial Contact - IC and Toe Off - TO) were detected from the angular velocities of the lower legs. For the determination of ground truth, the movement was simultaneously recorded with the AS-200 System (LaiTronic GmbH, Innsbruck, Austria). The number of detected strides, the error in IC detection and stance phase duration was calculated. In total, 1692 strides were detected from the reference system during the trials from which the AI-system identified 679 strides. The absolute mean error (AME) in IC detection was 39.3 ± 36.6 ms while the AME for stance duration was 187.6 ± 140 ms. Landmark detection is a challenging task for the AI-system as can clearly be seen be the rate of only 40% detected strides. As mentioned by Fadillioglu et al., error in TO-detection is higher than in IC-detection

Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts. Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion. Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure. The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease. This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming

Recently, a new generation of superior clavicle plates was developed featuring the variable-angle locking technology for enhanced screw positioning and optimized plate-to-bone fit design. On the other hand, mini-fragment plates used in dual plating mode have demonstrated promising clinical results. However, these two bone-implant constructs have not been investigated biomechanically in a human cadaveric model. Therefore, the aim of the current study was to compare the biomechanical competence of single superior plating using the new generation plate versus dual plating with low-profile mini-fragment plates. Sixteen paired human cadaveric clavicles were assigned pairwise to two groups for instrumentation with either a 2.7 mm Variable Angle Locking Compression Plate placed superiorly (Group 1), or with one 2.5 mm anterior plate combined with one 2.0 mm superior matrix mandible plate (Group 2). An unstable clavicle shaft fracture AO/OTA15.2C was simulated by means of a 5 mm osteotomy gap. All specimens were cyclically tested to failure under craniocaudal cantilever bending, superimposed with bidirectional torsion around the shaft axis and monitored via motion tracking. Initial stiffness was significantly higher in Group 2 (9.28±4.40 N/mm) compared to Group 1 (3.68±1.08 N/mm), p=0.003. The amplitudes of interfragmentary motions in terms of craniocaudal and shear displacement, fracture gap opening and torsion were significantly bigger over the course of 12500 cycles in Group 1 compared to Group 2; p≤0.038. Cycles to 2 mm shear displacement were significantly lower in Group 1 (22792±4346) compared to Group 2 (27437±1877), p=0.047. From a biomechanical perspective, low-profile 2.5/2.0 dual plates demonstrated significantly higher initial stiffness, less interfragmentary movements, and higher resistance to failure compared to 2.7 single superior variable-angle locking plates and can therefore be considered as a useful alternative for diaphyseal clavicle fracture fixation especially in unstable fracture configurations

Introduction. The main postoperative complications in fixation of ulna shaft fractures are non-union and implant irritation using currently recommended 3.5-mm locking compression plates. An alternative approach using a combination of two smaller plates in orthogonal configuration has been proposed. The aim of this study was to compare the biomechanical properties of a single 3.5-mm locking compression plate versus double plating using one 2.5-mm and one 2.0-mm mandible plate in a human ulna shaft fracture model. Method. Eight pairs human ulnar specimens with a standardized 10-mm fracture gap were pairwise assigned for instrumentation with either a single 3.5-mm plate placed posteriorly, or for double plating using a 2.5-mm and a 2.0-mm mandible plate placed posteriorly under the flexor muscles and laterally under the extensor muscles. All constructs were initially non-destructively biomechanically tested in axial compression, torsion, and bending, which was followed by cyclic torsional loading to failure. Interfragmentary movements were monitored by means of optical motion tracking. Result. There were no significant differences between the two plating techniques for axial stiffness (p=0.335), torsional stiffness in supination (p=0.462), torsional stiffness in pronation (p=0.307), medio-lateral bending stiffness (p=0.522), and antero-posterior bending stiffness (p=0.143). During cyclic torsional loading over the first 3000 cycles, there were no significant differences between the two plating techniques for shear displacement across the fracture gap, p=0.324. The numbers of cycles until clinically relevant failure of 5° angular deformation were 1366±685 for double plating and 2024±958 for single plating, which was statistically non-significantly different, p>0.05. The constructs treated with both plating techniques failed due to bone breakage at the most distal screw. Conclusion. From a biomechanical perspective double plating of ulna shaft fractures using a 2.5-mm and a 2.0-mm locking mandible plate demonstrated equivalent fixation strength as conventional plating using a single 3.5-mm locking compression plate