Introduction. Acetabular bone defects are still challenging to quantify. Numerous classification schemes have been proposed to categorize the diverse kinds of defects. However, these classification schemes are mainly descriptive and hence it remains difficult to apply them in pre-clinical testing, implant development and pre-operative planning. By reconstructing the native situation of a defect pelvis using a Statistical Shape Model (SSM), a more quantitative analysis of the bone defects could be performed. The aim of this study is to develop such a SSM and to validate its accuracy using relevant clinical scenarios and parameters. Methods. An SSM was built on the basis of segmented 66 CT dataset of the pelvis showing no orthopedic pathology. By adjusting the SSM's so called modes of shape variation it is possible to synthetize new 3D pelvis shapes. By fitting the SSM to intact normal parts of an anatomical structure, missing or pathological regions can be extrapolated plausibly. The validity of the SSM was tested by a Leave-one-out study, whereby one pelvis at a time was removed from the 66 pelvises and was reconstructed using a SSM of the remaining 65 pelvises. The reconstruction accuracy was assessed by comparing each original pelvis with its reconstruction based on the root-mean-square (RMS) surface error and five clinical parameters (center of rotation, acetabulum diameter, inclination, anteversion, and volume). The influence of six different numbers of shape variation modes (reflecting the degrees of freedom of the SSM) and four different mask sizes (reflecting different clinical scenarios) was analyzed. Results. The Leave-one-out study showed that the reconstruction errors decreased when the number of shape variation modes included in the SSM increased from 0 to 20, but remained almost constant for higher numbers of shape variation modes. For the SSM with 20 shape variation modes, the RMS of the reconstruction error increased with increasing mask size, whereas the other parameters only increased from Mask_0 to Mask_1, but remained almost constant for Mask_1, Mask_2 and Mask_3. Median reconstruction errors for Mask_1, Mask_2, and Mask_3 were approximately 3 mm in Center of Rotation (CoR) position, 2 mm in Diameter, 3° in inclination and anteversion, as well as 5 ml in volume. Discussion. This is the first study analyzing and showing the feasibility of a quantitative analysis of acetabular bone defects using a SSM-based reconstruction method in the clinical scenario of a defect or implant in both acetabuli and incomplete CT-scans.
The Manchester-Oxford Foot Questionnaire (MOxFQ) is a condition specific patient reported outcome measure (PROM) for foot and ankle surgery. It consists of 16 items across three subscales measuring distinct, but related traits: walking/standing ability, pain, and social interaction. Although it is the most used foot and ankle PROM in the UK, initial MOxFQ validation involved analysis of only 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual's response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ. This was a single-centre, prospective cohort study involving 6640 patients (mean age 52, range 10–90 years) presenting with a wide range of foot and ankle pathologies between 2013 and 2021. Firstly, to assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multi-group confirmatory factor analysis. Secondly, to assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed.Background
Methods
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.
PURPOSE: A new device for intraoperative pedography was developed. The purpose of this study was to validate the introduced method with standard dynamic pedography, and to analyze the clinical benefit. Methods: For an intraoperative introduction of standardized forces to the footsole, a device named Kraftsimulator Intraoperative Pedographie was developed. The validation was performed in two steps: Step 1. Comparison of standard dynamic pedography (three trials, walking, third step, three trials, mid stance force pattern), static pedography in standing position (three trials) and pedography with KIOP in healthy volunteers (three trials, total force 400 N).. Step 2. Comparison between pedography in standing position, pedography with KIOP in awake and anaesthesized patients (three trials, total force 400 N). A randomized prospective controlled study comparing treatment with and without intraoperative pedography has started on November 1, 2005. The subjects are randomized into two groups,. a) use of intraoperative pedography, versus. b) no use of intraoperative pedography. One-year-follow-up including standard dynamic pedography is planned. The following scores are used: American Orthopaedic Foot and Ankle Society (AOFAS), Visual-Analogue-Scale Foot and Ankle (VAS FA), Short-Form 36 (SF36, standardized to 100-point-maximum). Intraoperative consequences after the use of intraoperative pedography were recorded. Results:
Background: Researchers have measured exposure to sitting using self-reported questionnaires and observational analysis. Such methods are not a reliable measure of daily exposure or sensitive enough to take into account lumbar posture when seated. Recent innovations have produced a fibre-optic goniometer (FOG) that can continuously measure sagittal lumbar posture, although this single sensor is unable to identify if the user is sitting, standing or walking. Methods: A new system was developed utilising a second FOG attached to the hip. Movement characteristics of the hip and lumbar spine were described and used to develop software to predict activity (sitting, standing, walking). Subsequently 10 participants were asked to wear the FOGs for 8 minutes whilst their behaviour was recorded using a video camera. MPEG video sequences were produced and each activity was coded at a point in time and compared against the 2 FOG software model. Results: All Participants found the system comfortable to wear.
There is no consensus regarding the best method of assessing outcomes after total knee arthroplasty. There are now many questionnaires in the literature, well constructed and validated in the original language. Dawson’s questionnaire (1998) is designed as a 12-item self-administered instrument, and has undergone a complete validation procedure in its original English version. Aim of this paper is to present the procedure of cultural adaptation and some data from the validation process of the Italian version of the questionnaire. Two independent translations into Italian and back-translations into English were obtained, from specialised and general translators. The material was then evaluated in a multidisciplinary panel including elderly patients. A provisional version was obtained and tested in a pilot study. Results and comments were reviewed within the panel again which came up with the final version. The questionnaire was administered to 100 patients scheduled for knee replacement. Other outcomes collected included a general health questionnaire, in its validated Italian version (SF-36), and several objective and radiographic parameters. The burden on the patient and comprehension’s difficulties were registered.
In recent years, many studies on We investigated the reported Aim
Methods
Degenerative meniscal tears are the most common meniscal lesions, representing huge clinical and socio-economic burdens. Their role in knee osteoarthritis (OA) onset and progression is well established and demonstrated by several retrospective studies. Effective preventive measures and non-surgical treatments for degenerative meniscal lesions are still lacking, also because of the lack of specific and accurate animal models in which test them. Thus, we aim to develop and validate an accurate animal model of meniscus degeneration. Three different surgical techniques to induce medial meniscus degenerative changes in ovine model were performed and compared. A total of 32 sheep (stifle joints) were subjected to either one of the following surgical procedures: a) direct arthroscopic mechanical meniscal injury; b) peripheral devascularization and denervation of medial meniscus; c) full thickness medial femoral condyle cartilage lesion. In all the 3 groups, the contralateral joint served as a control.Introduction
Method
Artificial Intelligence (AI) is becoming more powerful but is barely used to counter the growth in health care burden. AI applications to increase efficiency in orthopedics are rare. We questioned if (1) we could train machine learning (ML) algorithms, based on answers from digitalized history taking questionnaires, to predict treatment of hip osteoartritis (either conservative or surgical); (2) such an algorithm could streamline clinical consultation. Multiple ML models were trained on 600 annotated (80% training, 20% test) digital history taking questionnaires, acquired before consultation. Best performing models, based on balanced accuracy and optimized automated hyperparameter tuning, were build into our daily clinical orthopedic practice. Fifty patients with hip complaints (>45 years) were prospectively predicted and planned (partly blinded, partly unblinded) for consultation with the physician assistant (conservative) or orthopedic surgeon (operative). Tailored patient information based on the prediction was automatically sent to a smartphone app. Level of evidence: IV. Random Forest and BernoulliNB were the most accurate ML models (0.75 balanced accuracy). Treatment prediction was correct in 45 out of 50 consultations (90%), p<0.0001 (sign and binomial test). Specialized consultations where conservatively predicted patients were seen by the physician assistant and surgical patients by the orthopedic surgeon were highly appreciated and effective. Treatment strategy of hip osteoartritis based on answers from digital history taking questionnaires was accurately predicted before patients entered the hospital. This can make outpatient consultation scheduling more efficient and tailor pre-consultation patient education.
Aim: The Système Française D’Arthroscopie (SFA) is a validated method of arthroscopic grading and scoring the knee OA. We have validated a modification of the SFA system for use with digital photographs of pathological samples. Material and Method: After Ethics Committee approval, both tibial plateaux and femoral condyles were collected from 84 patients undergoing total knee replacement or at post mortem. Extent and grading of cartilage changes were documented for the 4 compartments of each sample on a diagram using photographs at standard magnification and illumination, archived, (Photographic Scores).
The Forgotten Joint Score (FJS) is a 12-item patient reported outcome measurement instrument. It was developed with classical test theory, without testing assumptions such as unidimensionality (all items reflect one underlying factor), appropriate weighting of each item, no differential item function (DIF, different groups answer the same way), and monotonicity (people with higher function have higher score). We applied item response theory (IRT) to improve the validity of FJS to contemporary standards to optimise it for ongoing use. Does the FJS reflect one latent trait? Can an IRT model be fitted to the FJS to provide interval-scaled measurement?Abstract
Background
Research Questions
Malalignment is often postulated as the main reason for the high failure rate of total ankle replacements (TARs). Only a few studies have been performed to correlate radiographic TAR malalignment to the clinical outcome, but no consistent trends between TAR alignment parameters and the clinical outcome were found. No standard TAR alignment measurement method is present, so reliable comparison between studies is difficult. Standardizing TAR alignment measurements and increasing measurable parameters on radiographs in the clinic might lead to a better insight into the correlation between malalignment and the clinical outcome. This study aims to develop and validate a tool to semi-automatic measure TAR alignment, and to improve alignment measurement on radiographs in the clinic. A tool to semi-automatically measure TAR alignment on anteroposterior and lateral radiographs was developed and used by two observers to measure TAR alignment parameters of ten patients. The Intraclass Coefficient (ICC) was calculated and accuracy was compared to the manual measurement method commonly used in the clinic. The tool showed an accuracy of 76% compared to 71% for the method used during follow-up in the clinic. ICC values were 0.94 (p<0.01) and higher for both inter-and intra-observer reliability. The tool presents an accurate, consistent, and reliable method to measure TAR alignment parameters. Three-dimensional alignment parameters are obtained from two-dimensional radiographs, and as the tool can be applied to any TAR design, it offers a valuable addition in the clinic and for research purposes.
As there is currently no evidenced-based and systematic way of prioritising people requiring JRS we aimed to develop a clinically relevant system to improve prioritisation of people who may require JRS. An important challenge in this area is to accurately assign a queue position and improve list management. To identify priority criteria areas eight workshops were held with surgeons and patients. Domains derived were pain, activity limitations, psychosocial wellbeing, economic impact and deterioration. Draft questions were developed and refined through structured interviews with patients and consultation with consultants. 38 items survived critical appraisal and were mailed to 600 patients. Eleven items survived clinimetric and statistical item reduction.
There is growing evidence that bacteria encountered in periprosthetic joint infections (PJI) form surface-attached biofilms on prostheses, as well as biofilm aggregates embedded in synovial fluid and tissues. However, models allowing the investigation of these biofilms and the assessment of their antimicrobial susceptibility in physiologically relevant conditions are currently lacking. To address this, we developed a synthetic synovial fluid (SSF) model and we validated this model in terms of growth, aggregate formation and antimicrobial susceptibility testing, using multiple PJI isolates. 17 PJI isolates were included, belonging to Aim
Methods
OpenPredictor, a machine learning-enabled clinical decision aid, has been developed to manage backlogs in elective surgeries. It aims to optimise the use of high volume, low complexity surgical pathways by accurately stratifying patient risk, thereby facilitating the allocation of patients to the most suitable surgical sites. The tool augments elective surgical pathways by providing automated secondary opinions for perioperative risk assessments, enhancing decision-making. Its primary application is in elective sites utilising lighter pre-assessment methods, identifying patients with minimal complication risks and those high-risk individuals who may benefit from early pre-assessment. The Phase 1 clinical evaluation of OpenPredictor entailed a prospective analysis of 156 patient records from elective hip and knee joint replacement surgeries. Using a polynomial logistic regression model, patients were categorised into high, moderate, and low-risk groups. This categorisation incorporated data from various sources, including patient demographics, co-morbidities, blood tests, and overall health status. In identifying patients at risk of postoperative complications, OpenPredictor demonstrated parity with consultant-led preoperative assessments. It accurately flagged 70% of patients who later experienced complications as moderate or high risk. The tool's efficiency in risk prediction was evidenced by its balanced accuracy (75.6%), sensitivity (70% with a 95% confidence interval of 62.05% to 76.91%), and a high negative predictive value (96.7%). OpenPredictor presents a scalable and consistent solution for managing elective surgery pathways, comparable in performance to secondary consultant opinions. Its integration into pre-assessment workflows assists in efficient patient categorisation, reduces late surgery cancellations, and optimises resource allocation. The Phase 1 evaluation of OpenPredictor underscores its potential for broader clinical application and highlights the need for ongoing data refinement and system integration to enhance its performance.
Debridement, antibiotics irrigation and implant retention (DAIR) is a common management strategy for hip and knee prosthetic joint infections (PJI). However, failure rates remain high, which has led to the development of predictive tools to help determine success. These tools include KLIC and CRIME80 for acute-postoperative (AP) and acute haematogenous (AH) PJI respectively. We investigated whether these tools were applicable to a Waikato cohort. We performed a retrospective cohort study that evaluated patients who underwent DAIR between January 2010 and June 2020 at Waikato Hospital. Pre-operative KLIC and CRIME80 scores were calculated and compared to success of operation. Failure was defined as: (i) need for further surgery, (ii) need for suppressive antibiotics, (iii) death due to the infection. Logistic regression models were used to calculate the area under the curve (AUC).Introduction
Method
Freehand distal interlocking of intramedullary nails is technical demanding and prone to handling issues. It requires the surgeon to precisely place a screw through the nail under x-ray. If not performed accurately it can be a time consuming and radiation expensive procedure. The aims of this study were to assess construct and face validity of a new training device for distal interlocking of intramedullary nails. 53 participants (29 novices and 24 experts) were included. Construct validity was evaluated by comparing simulator metrics (number of x-rays, nail hole roundness, drill tip position and accuracy of the drilled hole) between experts and novices. Face validity was evaluated by means of a questionnaire concerning training potential and quality of simulated reality using a 7-point Likert scale (range 1-7). Mean realism of the training device was rated 6.3 (range 4-7) and mean training potential as well as need for distal interlocking training was rated 6.5 (range 5-7) with no significant differences between experts and novices, p≥0.236. All participants stated that the simulator is useful for procedural training of distal nail interlocking, 96% would like to have it at their institution and 98% would recommend it to their colleagues. Total number of x-rays were significantly higher for novices (20.9±6.4 vs. 15.5±5.3), p=0.003. Successful task completion (hit the virtual nail hole with the drill) was significantly higher in experts (p=0.04; novices hit: n=12; 44,4%; experts hit: n=19; 83%). The evaluated training device for distal interlocking of intramedullary nails yielded high scores in terms of training capability and realism. Furthermore, construct validity was established as it reliably discriminates between experts and novices. Participants see a high further training potential as the system may be easily adapted to other surgical task requiring screw or pin position with the help of x-rays.
Purpose of the study: The mean rotation center (MRC) characterizes the movement of two solids in relation to each other. This parameter has been proposed for the cervical spine to describe the motion of vertebral segments. Two lateral views (flexion and extension) are required to draw the necessary lines and establish the centers of rotation. The process is rigorous but time-consuming. We validated a computerized analysis system for automatic determination of the cervical MRC and study the localizations observed in healthy subjects. Material and methods:
Heterotopic ossification is the formation of extraskeletal mineralized tissue commonly associated with either trauma or surgery. While several mouse models have been developed to better characterize the pathologic progression of HO, no model currently exists to study HO of the hip, the most common location of acquired HO in patients. Owing to the unique biological mechanisms underpinning the formation of HO in different tissues, we sought to develop a model to study the post-surgical HO of the hip. Wild-type mice C57BL/6J mice were used to study the procedure outcomes, while Pdgfra-CreERT2;mT/mG and Scx-GFP reporter animals were used for the lineage tracing experiments (total n=16 animals, male, 12 weeks old). An anterolateral approach to the hip was performed. Briefly, a 2 cm incision was made centered on the great trochanter and directed proximal to the iliac crest and distally over the lateral shaft of the femur. The joint was then reached following the intermuscular plane between the rectus femoris and gluteus medius muscles. After the joint was exposed, the articular cartilage was removed using a micropower drill with a 1.2 mm reamer. The medius gluteus and superficial fascia were then re-approximated with Vicryl 5-0 suture (Ethicon Inc, Somerville, NJ) and skin was then closed with Ethilon 5-0 suture (Ethicon Inc). Live high resolution XR imaging was performed every 2 wks to assess the skeletal tissues (Faxitron Bioptics, Tucson, AZ). The images were then scored using the Brooker classification. Ex-vivo microCT was conducted using a Skyscan 1275 scanner (Bruker-MicroCT, Kontich, Belgium). 3D reconstruction and analysis was performed using Dragonfly (ORS Inc., Montreal, Canada). For the histological analysis of specimens, Hematoxylin and Eosin (H&E), modified Goldner's Trichrome (GMT) stainings were performed. Reporter activity was assessed using fluorescent imaging.Introduction and Objective
Materials and Methods
Software to segment and to analyse connective CT-scan images of the bone-cement-stem complex was developed and validated. Parameters assessed included: volumes (cortical bone, cancelous bone, cement, stem, air in bone and air in cement), cement mantle thickness, cortical &
cancelous bone thickness, contact surface area between cement and bone, degree of centralisation (stem in cement, stem and cement in cancelous and in cortical bone). To validate and assess intra- and interob-server reliability two models were implanted in two dried macerated cadaver femurs using a third generation cementing technique. In the first a polished tapered stem (CPT, Zimmer) was cemented and removed after cement curing. The air filled cavity within the cement mantle could be identified as implant, avoiding metallic scatter artefacts. The second model (SLA) used a plastic stem prototype produced by computer design and a rapid prototyping stereolithographic technique. This model does not need to be removed before CT-scanning and allows assessment of whatever femoral implant.