3D accurate measurements of the skeletal structures of the foot, in physiological and impaired subjects, are now possible using Cone-Beam CT (CBCT) under real-world loading conditions. In detail, this feature allows a more realistic representation of the relative bone-bone interactions of the foot as they occur under patient-specific body weight conditions. In this context, varus/valgus of the hindfoot under altered conditions or the thinning of plantar tissues that occurs with advancing age are among the most complex and interesting to represent, and numerous measurement proposals have been proposed. This study aims to analyze and compare these measurements from CBCT in weight-bearing scans in a clinical population. Sixteen feet of diabetic patients and ten feet with severe adult flatfoot acquired before/after corrective surgery underwent CBCT scans (Carestream, USA) while standing on the leg of interest. Corresponding 3D shapes of each bone of the shank and hindfoot were reconstructed (Materialise, Belgium). Six different techniques found in the literature were used to calculate the varus/valgus deformity, i.e., the inclination of the hindfoot in the frontal plane of the shank, and the distance between the ground and the metatarsal heads was calculated along with different solutions for the identification of possible calcifications. Starting with an accurate 3D reconstruction of the skeletal structures of the foot, a wide range of measurements representing the same angle of hindfoot alignment were found, some of them very different from each other. Interesting correlations were found between metatarsal height and subject age, significant in diabetic feet for the fourth and fifth metatarsal bones. Finally, CBCT allows 3D assessment of foot deformities under loaded conditions. The observed traditional measurement differences and new measurement solutions suggest that clinicians should consider carefully the anatomical and functional concepts underlying measurement techniques when drawing clinical and surgical conclusions.

High tibial osteotomy (HTO) is a joint preserving alternative to knee replacement for medial tibiofemoral osteoarthritis in younger, more active patients. The procedure is technically challenging and limited also by ‘one size fits all’ plates which can result in patient discomfort necessitating plate removal.

This clinical trial evaluated A novel custom-made HTO system – TOKA (3D Metal Printing LTD, Bath, UK) for accuracy of osteotomy correction and improvements in clinical outcome scores.

The investigation was a single-arm single-centre prospective clinical trial (IRCCS Istituto Ortopedico Rizzoli; ClinicalTrials.gov NCT04574570), with recruitment of 25 patients (19M/6F; average age: 54.4 years; average BMI: 26.8), all of whom received the TOKA HTO 3D planning and surgery. All patients were predominantly diagnosed with isolated medial knee osteoarthritis and with a varus deformity under 20°. Patients were CT scanned pre- and post-operatively for 3D virtual planning and correctional assessment. All surgeries were performed by the lead clinical investigator – a consultant knee surgeon with a specialist interest in and clinical experience of HTO.

On average, Knee Society Scores (KSS) improved significantly (p<0.001) by 27.6, 31.2 and 37.2 percentage points respectively by 3-, 6- and 12-months post-surgery respectively. Other measures assessed during the study (KOOS, EQ5D) produced similar increases.

Our early experience using custom implants is extremely promising. We believe the reduced profile of the plate, as well as the reduced invasiveness and ease of surgery contributed to faster patient recovery, and improved outcome scores compared to conventional techniques. These clinical outcome results compare very favourably other case-series with published KOOS scores using different devices.

Biomedical imaging is essential in the diagnosis of musculoskeletal pathologies and postoperative evaluations. In this context, Cone-Beam technology-based Computed Tomography (CBCT) can make important contributions in orthopaedics. CBCT relies on divergent cone X-rays on the whole field of view and a rotating source-detector element to generate three-dimensional (3D) volumes. For the lower limb, they can allow acquisitions under real loading conditions, taking the name Weight-Bearing CBCT (WB-CBCT). Assessments at the foot, ankle, knee, and at the upper limb, can benefit from it in situations where loading is critical to understanding the interactions between anatomical structures. The present study reports 4 recent applications using WB-CBCT in an orthopaedic centre.

Patient scans by WB-CBCT were collected for examinations of the lower limb in monopodal standing position. An initial volumetric reconstruction is obtained, and the DICOM file is segmented to obtain 3D bone models. A reference frame is then established on each bone model by virtual landmark palpation or principal component analysis. Based on the variance of the model point cloud, this analysis automatically calculates longitudinal, vertical and mid-lateral axes. Using the defined references, absolute or relative orientations of the bones can be calculated in 3D.

In 19 diabetic patients, 3D reconstructed bone models of the foot under load were combined with plantar pressure measurement. Significant correlations were found between bone orientations, heights above the ground, and pressure values, revealing anatomic areas potentially prone to ulceration. In 4 patients enrolled for total ankle arthroplasty, preoperative 3D reconstructions were used for prosthetic design customization, allowing prosthesis-bone mismatch to be minimized. 20 knees with femoral ligament reconstruction were acquired with WB-CBCT and standard CT (in unloading). Bone reconstructions were used to assess congruency angle and patellar tilt and TT-TG. The values obtained show differences between loading and unloading, questioning what has been observed so far. Twenty flat feet were scanned before and after Grice surgery. WB-CBCT allowed characterization of the deformity and bone realignment after surgery, demonstrating the complexity and multi-planarity of the pathology.

These applications show how a more complete and realistic 3D geometric characterization of the of lower limb bones is now possible in loading using WB-CBCT. This allows for more accurate diagnoses, surgical planning, and postoperative evaluations, even by automatisms. Other applications are in progress.

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

Introduction and Objective

Medial Knee Osteoarthritis (MKO) is associated with abnormal knee varism, this resulting in altered locomotion and abnormal loading at tibio-femoral condylar contacts. To prevent end-stage MKO, medial compartment decompression is selectively considered and, when required, executed via High Tibial Osteotomy (HTO). This is expected to restore normal knee alignment, load distribution and locomotion. In biomechanics, HTO efficacy may be investigated by a thorough analysis of the ground reaction forces (GRF), whose orientation with respect to patient-specific knee morphology should reflect knee misalignment. Although multi-instrumental assessments are feasible, a customized combination of medical imaging and gait analysis (GA), including GRF data, rarely is considered. The aim of this study was to report an original methodology merging Computed-Tomography (CT) with GA and GFR data in order to depict a realistic patient-specific representation of the knee loading status during motion before and after HTO.

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

Total ankle replacement (TAR) is the main surgical option in case of severe joint osteoarthritis. The high failure rate of current TAR is often associated to inappropriate prosthetic articulating surfaces designed according to old biomechanical concepts such the fixed axis of rotation, thus resulting in non-physiological joint motion. A recent image-based 3D morphological study of the normal ankle (Siegler et al. 2014) has demonstrated that the ankle joint surfaces can be approximated by a saddle-shaped cone with its apex located laterally (SSCL). We aimed at comparing the kinematic effects of this original solution both with the intact joint and with the traditional prosthetic articulating surfaces via in-silico models and in-vitro measurements.

Native 3D morphology of ten normal cadaver ankle specimens was reconstructed via MRI and CT images. Three custom-fit ankle joint models were then developed, according to the most common TAR designs: cylindrical, symmetrically-truncated medial apex cone (as in Inman's pioneering measures), and the novel lateral apex cone, i.e. SSCL. Bone-to-bone motion, surface-to-surface distance maps, and ligament forces and deformations were evaluated via computer simulation. Prototypes of corresponding prosthesis components were designed and manufactured via 3D-printing, both in polymer-like-carbon and in cobalt-chromium-molybdenum powders, for in-vitro tests on the cadaver specimens. A custom testing rig was used for application of external moments to the ankle joint in the three anatomical planes; a motion tracking system with trackers pinned into the bone was used to measure tibial, talar and calcaneal motion (Franci et al. 2009), represented then as tibiotalar, subtalar and ankle complex 3D joint rotations. Each ankle specimen was tested in the intact joint configuration and after replacement of the articulating surfaces according with the three joint models: cylindrical, medial apex cone and SSCL.

Results. Small intra-specimen data variability in cycle-to-cycle joint kinematics was found in all cadaver ankles, the maximum standard deviation of all rotation patterns being smaller than 2.0 deg. In-silico ligament strain/stress analysis and in-vitro joint kinematic and load transfer measurements revealed that the novel SSCL surfaces reproduce more natural joint patterns than those with the most common surfaces used in current TAR.

TAR based on a saddle-shaped skewed truncated cone with lateral apex is expected to restore more normal joint function. Additional tests are undergoing for further biomechanical validation. The present study has also demonstrated the feasibility and the quality of the full process of custom TAR design and production for any specific subject. This implies a thorough procedure, from medical imaging to the production of artificial surfaces via 3D printing, which is allowing for personalised implants to become the future standard in total joint replacement.