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.

Background

Total Ankle Replacement (TAR) has become a common surgical procedure for severe Osteoarthritis of the ankle. Unlike hip and knee, current TARs still suffer from high failure rates. A key reason could be their non-anatomical surface geometry design, which may produce unnatural motion and load-transfer characteristics. Current TARs have articular surfaces that are either cylindrical or truncated cone surfaces following the Inman truncated cone concept from more than 60 years ago [1]. Our recent study demonstrated, that the surfaces of the ankle can be approximated by a Saddle-shaped, Skewed, truncated Cone with its apex directed Laterally (SSCL) [2]. This is significantly different than the surface geometry used in current TAR systems. The goal of this study was to develop and test the reliability of an in vitro procedure to investigate the effect of different joint surface morphologies on the kinematics of the ankle and to use it to compare the effect of different joint surface morphologies on the 3D kinematics of the ankle complex.

The flat foot is a frequent deformity in children and results in various levels of functional alterations. A diagnosis based on foot morphology is not sufficient to define the therapeutic approach. In fact, the degree of severity of the deformity and the effects of treatments require careful functional assessment. In case of functional flatfoot, subtalar arthroereisis is the surgical treatment of choice. The aim of this study is to evaluate and compare the functional outcomes of two different bioabsorbable implants designed for subtalar arthroereisis in childhood severe flat foot by means of thorough gait analysis.

Ten children (11.3 ± 1.6 yrs, 19.7 ± 2.8 BMI) were operated for flat foot correction [1,2] in both feet, one with the calcaneo-stop method, i.e. a screw implanted into the calcaneus, the other with an endoprosthesis implanted into the sinus-tarsi. Gait analysis was performed pre- and 24 month post-operatively using a 8-camera motion system (Vicon, UK) and a surface EMG system (Cometa, Italy) to detect muscular activation of the main lower limb muscles. A combination of established protocols, for lower limb [3] and multi-segment foot [4] kinematic analysis, was used to calculate joint rotations and moments during three level walking trials for each patient. At the foot, the tibio-talar, Chopart, Lisfranc, 1^st metatarso-phalangeal joints were tracked in three-dimensions, together with the medial longitudinal arch.

Significant differences in standard X-ray measurements were observed between pre- and post-op, but not between the two treatment groups. Analysis of the kinematic variables revealed functional improvements after surgery. In particular, a reduction of eversion between the shank and calcaneus (about 15° on average) and a reduction of inversion between metatarsus and calcaneus (about 18° on average) were detected between pre- and post-operatively after both treatments. Activation of the main plantar/dorsiflexor muscles was similar at both pre- and post-op assessments with both implants.

The combined lower limb and multi-segment foot kinematic analyses were found adequate to provide accurate functional assessment of the feet and of the lower limbs. Both surgical treatments restored nearly normal kinematics of the foot and of the lower limb joints, associated also to a physiologic muscular activation.

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

In podiatric medicine, diagnosis of foot disorders is often merely based on tests of foot function in static conditions or on visual assessment of the patient's gait. There is a lack of tools for the analysis of foot type and for diagnosis of foot ailments. In fact, static footprints obtained via carbon paper imprint material have traditionally been used to determine the foot type or highlight foot regions presenting excessive plantar pressure, and the data currently available to podiatrists and orthotists on foot function during dynamic activities, such as walking or running, are scarce.

The device presented in this paper aims to improve current foot diagnosis by providing an objective evaluation of foot function based on pedobarographic parameters recorded during walking.

23 healthy subjects (16 female, 7 males; age 35 ± 15 years; weight 65.3 ± 12.7; height 165 ± 7 cm) with different foot types volunteered in the study. Subjects' feet were visually inspected with a podoscope to assess the foot type. A tool, comprised of a 2304-sensor pressure plate (P-walk, BTS, Italy) and an ad-hoc software written in Matlab (The Mathworks, US), was used to estimate plantar foot morphology and functional parameters from plantar pressure data. Foot dimensions and arch-index, i.e. the ratio between midfoot and whole footprint area, were assessed against measurements obtained with a custom measurement rig and a laser-based foot scanner (iQube, Delcam, UK).

The subjects were asked to walk along a 6m walkway instrumented with the pressure plate. In order to assess the tool capability to discriminate between the most typical walking patterns, each subject was asked to walk with the foot in forcibly pronated and supinated postures. Additionally, the pressure plate orientation was set to +15°, +30°, −15° and −30° with respect to the walkway main direction to assess the accuracy in measuring the foot progression angle (i.e. the angle between the foot axis and the direction of walk). At least 5 walking trials were recorded for each foot in each plate configuration and foot posture.

The device allowed to estimate foot length with a maximum error of 5% and foot breadth with an error of 1%. As expected, the arch-index estimated by the device was the lowest in the cavus-feet group (0.12 ± 0.04) and the highest in the flat-feet group (0.29 ± 0.03). These values were between 4 – 10 % lower than the same measurements obtained with the foot scanner. The centre of pressure excursion index [1] was the lowest in the forcibly-pronated foot and the largest in the supinated foot.

While the pressure plate used here has some limitations in terms of spatial resolution and sensor technology [2], the tool appears capable to provide information on foot morphology and foot function with satisfying accuracy. Patient's instrumental examination takes only few minutes and the data can be used by podiatrists to improve the diagnosis of foot ailments, and by orthotists to design or recommend the best orthotics to treat the foot condition.

Biomechanical interpretations of bone adaptation in biological reconstructions following bone tumors would be crucial for orthopedic oncologists, particularly if based on quantitative observations. This would help to plan for surgical treatments, rehabilitative programs and communication with the patients. In particular, outcomes of the Capanna technique, which combines bone allograft and vascularized fibula autograft, lead to stable and durable reconstructions [1, 2], and different remodeling patterns have been described [3] as a response to mechanical loading. However, there are several events that are not understood and require a biomechanical interpretation, as the evolution patterns can evolve towards conditions that threaten the strength of the reconstruction.

We aimed to (i) analyze the biomechanical adaptation of a femoral reconstruction after Ewing sarcoma, in terms of morphological and densitometric evolution of bone from CT data, internal loads acting on the bone during movement, mechanical competence of the reconstruction, and (ii) relate in-progress bone resorption to the mechanical stimulus induced by different motor activities.

Eight CT datasets of a patient (8 yrs at surgery using the Capanna technique) during 76-month follow-up were available. The evolution of bone morphology, density and moments of inertia was quantified. At the last control, the patient underwent gait analysis (walking, chair rise/sit, stair ascent/descent, squat).

We created a multiscale musculoskeletal and finite element model from CT scans and motion analysis data at the end of follow-up, using state-of-the-art modeling workflows [4, 5], to analyze muscle and joint loads, and to compare the mechanical competence of the reconstructed bone with the contralateral limb, in the current real condition and in a possible revision surgery that removed proximal screws.

Although there were no reconstruction complications and osteo-fusion with intense remodeling between allograft and autograft was shown, there was a progressive decrease in allograft cortical thickness and density. There were strategies of muscle coordination that led to differences in joint loads between limbs more marked in more demanding motor activities, and generally larger in the contralateral limb. The operated femur presented a markedly low ratio of physiological strain due to load-sharing with the metal implant, particularly in the lateral aspect. A possible revision surgery removing the three most proximal screws would help restore a physiological strain configuration, while the safety of the reconstruction would not be threatened.

We suggest that bone resorption is related to load-sharing and to the internal forces exerted during movement, and the mechanical stimulus should be improved by adopting modifications in the surgical treatment and by promoting physical therapy aimed at specific muscle strengthening.

Rehabilitation systems based on inertial measurement units (IMU) and bio-feedbacks are increasingly used in many different settings for patients with neurological disorders such as Parkinson disease or balance impairment, and more recently for functional recover after orthopedic surgical interventions or injuries especially concerning the lower limb. These systems claim to provide a more controlled and correct execution of the motion exercises to be performed within the rehabilitation programs, hopefully resulting in a better outcomes with respect to the traditional direct support of a physical therapists. In particular recruitment of specific muscles during the exercise is expression of its correct and finalized execution. The objective of this study was to compare muscular activation patterns of relevant lower limb muscles during different exercises performed with traditional rehabilitation and with a new validated system based on IMU and biofeedback (Riablo, Corehab, Trento, Italy).

Twelve healthy subjects (mean age 28.1 ± 3.9, BMI 21.8± 2.1) were evaluated in a rehabilitation center. Muscular activation pattern of gluteus maximum, gluteus medium, rectus femoris and biceps femoris was recorded through surface EMG (Cometa; Milan) during six different motion tasks: hip abduction in standing position, lunge, hip flexion with extended knee in standing position, lateral lunge, hip abduction with extended knee in lateral decubitus, squat. Subjects performed 10 repetitions of each task for a total of 100 repetitions per motion task, with and without Riablo System as well as during standard rehabilitation. An additional IMU was positioned on the shank in order to detect beginning and end of each repetition. A single threshold algorithm was used to identify muscle activation timing.

During hip abduction in standing position, gluteus maximum and rectus femoris showed a better and longer activation pattern while using Riablo compared to traditional rehabilitation. Gluteus medium showed a similar activation pattern whereas biceps femoris showed no activation from 30% to 80% using Riablo. During squat, rectus femoris and biceps femoris had a similar activation pattern with and without Riablo whereas gluteus maximum and gluteus medium showed a better activation pattern while using Riablo.

The recent development of innovative rehabilitation systems meets the need of manageable, reliable and efficient instruments able to reduce rehabilitation costs but with the same good clinical outcomes. Muscular activation patterns of relevant lower limb muscles during selected motion tasks reveal their correct execution. The use of this new rehabilitation system based on IMU and biofeedback seems to allow a more selective and effective muscular recruitment, likely due to the more correct and controlled execution of the exercise, particularly for the identification and interdiction of possible compensation mechanisms.

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.

Introduction

Total knee arthroplasty (TKA) is a consolidated orthopaedic procedure and success of such operation depends on the prosthetic design [1]. Unfortunately, as there is a good survival rate of primary TKA, failures occur for factors concerning the polyethylene composition of the implants, secondary osteolysis, and ultimately loosening of the implants are the usual causes of failure after normal use [2]. Dynamic in vitro testing of the human knee continues to be an area of interest to the orthopaedic biomechanics community. The scope of this work was to assess pre-clinically the wear behaviour of polyethylene knee insert under a realistic stair climbing activity using a displacement knee simulator.

INTRODUCTION

In total knee arthroplasty (TKA), the effectiveness of the mechanical alignment (MA) within 0°±3° has been recently questioned. A novel implantation approach, i.e. the kinematic alignment (KA), emerged recently, this being based on the pre-arthritic lower-limb alignment. In KA, the trans-cylindrical axis is used as the reference, instead of the trans-epicondylar one, for femoral component alignment. This axis is defined as the line passing through the centres of the posterior femoral condyles modeled as cylinders. Recently, patient specific instrumentation (PSI) has been introduced in TKA as an alternative to conventional instrumentation. This provides a tool for preoperative implant planning also via KA. Particularly, KA using PSI seems to be more effective in restoring normal joint kinematics and muscle activity.

The purpose of this study was to report preliminarily joint kinematic and electromyography results of two patient groups operated via conventional MA or KA, the latter using PSI.

INTRODUCTION

In computer-aided total knee arthroplasty (TKA), surgical navigation systems (SNS) allow accurate tibio-femoral joint (TFJ) prosthesis implantation only. Unfortunately, TKA alters also normal patello-femoral joint (PFJ) functioning. Particularly, without patellar resurfacing, PFJ kinematics is influenced by TFJ implantation; with resurfacing, this is further affected by patellar implantation. Patellar resurfacing is performed only by visual inspections and a simple calliper, i.e. without computer assistance.

Patellar resurfacing and motion via patient-specific bone morphology had been assessed successfully in-vitro and in-vivo in pilot studies aimed at including these evaluations in traditional navigated TKA.

The aim of this study was to report the current experiences in-vivo in two patient cohorts during TKA with patellar resurfacing.

INTRODUCTION

In Total Knee Arthroplasty (TKA), the neutral overall limb alignment (NOLA), i.e. the mechanical alignment of the lower limb within 0°±3°, is targeted for achieving good clinical/functional results. The kinematic overall limb alignment (KOLA), which uses the axis through the centres of the femur posterior condyles modelled as cylinders, represents a novel approach for achieving better soft tissue balance.

Patient-specific instrumentation (PSI) is nowadays offered as an effective technology in TKA to obtain better lower limb alignments than those via conventional guides (CON). Although relevant results are still inconsistent, the benefits claimed include shorter operative time, reduced surgical instrumentation, and accurate preoperative planning.

The aim of this study was to report the preliminary clinical and radiological results of TKA patients operated via NOLA-PSI and KOLA-PSI. Comparisons between them and with the results obtained via NOLA-CON were performed.

INTRODUCTION

Despite a large percentage of total knee arthroplasty failures occurs for disorders at the patello-femoral joint (PFJ), current navigation systems report tibio-femoral (TFJ) kinematics only, and do not track the patella. Despite this tracking is made difficult by the small bone and by its full eversion during surgery, a new such technique has been developed, which includes a new tracker, new corresponding surgical instrumentation also for patellar resurfacing, and all relevant software. The aim of this study is to report an early experience in patients of these measurements, i.e. TFJ and PFJ kinematics.

During total knee replacement (TKR), knee surgical navigation systems (KSNS) report in real time relative motion data between the tibia and the femur from the patient under anaesthesia, in order to identify best possible locations for the corresponding prosthesis components. These systems are meant to support the surgeon for achieving the best possible replication of natural knee motion, compatible with the prosthesis design and the joint status, in the hope that this kinematics under passive condition will be then the same during the daily living activities of the patient. Particularly, by means of KSNS, knee kinematics is tracked in the original arthritic joint at the beginning of the operation, intra-operatively after adjustments of bone cuts and trial components implantation, and after final components implantation and cementation. Rarely the extent to which the kinematics in the latter condition is then replicated during activity is analysed. As for the assessment of the active motion performance, the most accurate technique for the in-vivo measurements of replaced joint kinematics is three-dimensional video-fluoroscopy. This allows joint motion tracking under typical movements and loads of daily living. The general aim of this study is assessing the capability of the current KSNS to predict replaced joint motion after TKR. Particularly, the specific objective is to compare, for a number of patients implanted with two different TKR prosthesis component designs, knee kinematics obtained intra-operatively after final component implantation measured by means of KSNS with that assessed post-operatively at the follow-up by means of three-dimensional video-fluoroscopy.

Thirty-one patients affected by primary gonarthrosis were implanted with a fixed bearing posterior-stabilized TKR design, either the Journey® (JOU; Smith&Nephew, London, UK) or the NRG® (Stryker®-Orthopaedics, Mahwah, NJ-USA). All implantations were performed by means of a KSNS (Stryker®-Leibinger, Freiburg, Germany), utilised to track and store joint kinematics intra-operatively immediately after final component implantation (INTRA-OP). Six months after TKR, the patients were followed for clinical assessment and three-dimensional video fluoroscopy (POST-OP). Fifteen of these patients, 8 with the JOU and 7 with the NRG, gave informed consent and these were analyzed. At surgery (INTRA-OP), a spatial tracker of the navigation system was attached through two bi-cortical 3 mm thick Kirschner wires to the distal femur and another to the proximal tibia. The conventional navigation procedure recommended in the system manual was performed to calculate the preoperative deformity including the preoperative lower limb alignment, to perform the femoral and tibial bone cuts, and to measure the final lower limb alignment. All these assessment were calculated with respect to the initial anatomical survey, the latter being based on calibrations of anatomical landmarks by an instrumented pointer. Patients were then analysed (POST-OP) by three-dimensional video-fluoroscopy (digital remote-controlled diagnostic Alpha90SX16; CAT Medical System, Rome-Italy) at 10 frames per second during chair rising-sitting, stair climbing, and step up-down. A technique based on CAD-model shape matching was utilised for obtaining three-dimensional pose of the prosthesis components. Between the two techniques, the kinematics variables analysed for the comparison were the three components of the joint rotation (being the relative motion between the tibial and femoral components represented using a standard joint convention, the translation of the line through the medial and lateral contact points (being these points assumed to be where the minimum distance between the femoral condyles and the tibial baseplate is observed) on the tibial baseplate and the corresponding pivot point, and the location of the instantaneous helical axes with the corresponding mean helical axis and pivot point.

In all patients and in both conditions, physiological ranges of flexion (from −5° to 120°), and ab-adduction (±5°) were observed. Internal-external rotation patterns are different between the two prostheses, with a more central pivoting in NRG and medial pivoting in JOU, as expected by the design. Restoration of knee joint normal kinematics was demonstrated also by the coupling of the internal rotation with flexion, as well as by the roll-back and screw-home mechanisms, observed somehow both in INTRA- and POST-OP measurements. Location of the mean helical axis and pivot point, both from the contact lines and helical axes, were very consistent over time, i.e. after six months from intervention and in fully different conditions. Only one JOU and one NRG patient had the pivot point location POST-OP different from that INTRA-OP, despite cases of paradoxical translation.

In all TKR knees analysed, a good restoration of normal joint motion was observed, both during operation and at the follow-up. This supports the general efficacy of the surgery and of both prosthesis designs. Particularly, the results here reported show a good consistency of the measurements over time, no matter these were taken in very different joint conditions and by means of very different techniques. Intra-operative kinematics therefore does matter, and must be taken into careful consideration for the implantation of the prosthesis components. Joint kinematics should be tracked accurately during TKR surgery, and for this purpose KSNS seem to offer a very good support. These systems not only supports in real time the best possible alignment of the prosthesis components, but also make a reliable prediction of the motion performance of the replaced joint. Additional analyses will be necessary to support this with a statistical power, and to identify the most predicting parameters among the many kinematics variables here analysed preliminarily.

During total knee replacement (TKR), surgical navigation systems (SNS) allow accurate prosthesis component implantation by tracking the tibio-femoral joint (TFJ) kinematics in the original articulation at the beginning of the operation, after relevant trial components implantation, and, ultimately, after final component implantation and cementation. It is known that TKR also alters normal patello-femoral joint (PFJ) kinematics resulting frequently in PFJ disorders and TKR failure. More importantly, patellar tracking in case of resurfacing is further affected by patellar bone preparation and relevant component positioning. The traditional technique used to perform patellar resurfacing, even in navigated TKR, is based only on visual inspection of the patellar articular aspect for clamping patellar cutting jig and on a simple calliper to check for patellar thickness before and after bone cut, and, thus, without any computer assistance. Even though the inclusion in in-vivo navigated TKR of a procedure for supporting also patellar resurfacing based on patient-specific bone morphology seems fundamental, this have been completely disregarded till now, whose efficacy being assessed only in-vitro. This procedure has been developed, together with relevant software and surgical instrumentation, as an extension of current SNS, i.e. TKR is navigated, at the same time measuring the effects of every surgical action on PFJ kinematics. The aim of this study was to report on the first in-vivo experiences during TKR with patellar resurfacing.

Four patients affected by primary gonarthrosis were implanted with a fixed bearing posterior-stabilised prosthesis (NRG, Stryker®-Orthopaedics, Mahwah, NJ-USA) with patellar resurfacing. All TKR were performed by means of two SNS (Stryker®-Leibinger, Freiburg, Germany) with the standard femoral/tibial trackers, the pointer, and a specially-designed patellar tracker. The novel procedure for patellar tracking was approved by the local ethical committee; the patients gave informed consent prior the surgery. This procedure implies the use of a second system, i.e. the patellar SNS (PSNS), with dedicated software for supporting patellar resurfacing and relative data processing/storing, in addition to the traditional knee SNS (KSNS). TFJ anatomical survey and kinematics data are shared between the two. Before surgery, both systems were initialised and the patellar tracker was assembled with a sterile procedure by shaping a metal grid mounted with three markers to be tracked by PSNS only. The additional patellar-resection-plane and patellar-cut-verification probes were instrumented with a standard tracker and a relevant reference frame was defined on these by digitisation with PSNS. Afterwards, the procedures for standard navigation were performed to calculate preoperative joint deformities and TFJ kinematics. The anatomical survey was performed also with PSNS, with relevant patellar anatomical reference frame definition and PFJ kinematics assessment according to a recent proposal. Standard procedures for femoral and tibial component implantation, and TFJ kinematics assessment were then performed by using relevant trial components. Afterwards, the procedure for patellar resection begun. Once the surgeon had arranged and fixed the patellar cutting jig at the desired position, the patellar-resection-plane probe was inserted into the slot for the saw blade. With this in place, the PSNS captured tracker data to calculate the planned level of patellar bone cut and the patellar cut orientation. Then the cut was executed, and the accuracy of this actual bone cut was assessed by means of the patellar-cut-verification probe. The trial patellar component was positioned, and, with all three trial components in place, TFJ and PFJ kinematics were assessed. Possible adjustments in component positioning could still be performed, until both kinematics were satisfactory. Finally, final components were implanted and cemented, and final TFJ and PFJ kinematics were acquired. A sterile calliper and pre- and post-implantation lower limb X-rays were used to check for the patellar thickness and final lower limb alignment. The novel surgical technique was performed successfully in all four cases without complication, resulting in 30 min longer TKR. The final lower limb alignment was within 0.5°, the resurfaced patella was 0.4±1.3 mm thinner than in the native, the patellar cut was 1.5°±3.0° laterally tilted. PFJ kinematics was taken within the reference normality. The patella implantation parameters were confirmed also by X-ray inspection; discrepancies in thickness up to 5 mm were observed between SNS- and calliper-based measurements.

At the present experimental phase, a second separate PSNS was utilised not to affect the standard navigated TKR. The results reported support relevance, feasibility and efficacy of patellar tracking and PFJ kinematics assessment in in-vivo navigated TKR. The encouraging in-vivo results may lay ground for the design of a future clinical patella navigation system the surgeon could use to perform a more comprehensive assessment of the original whole knee anatomy and kinematics, i.e. including also PFJ. Patellar bone preparation would be supported for suitable patellar component positioning in case of resurfacing but, conceptually, also in not resurfacing if patellar anatomy and tracking assessment by SNS reveals no abnormality. After suitable adjustment and further tests, in the future if this procedure will be routinely applied during navigated TKR, abnormalities at both TFJ and PFJ can be corrected intra-operatively by more cautious bone cut preparation on the femur, tibia and also patella, in case of resurfacing, and by correct prosthetic component positioning.

Restoration of natural range and pattern of motion is the primary goal of joint replacement. In total ankle replacement, proper implant positioning is a major requirement to achieve good clinical results and to prevent instability, aseptic loosening, meniscal bearing premature wear and dislocation at the replaced ankle. The current operative techniques support limitedly the surgeon in achieving a best possible prosthetic component alignment and in assessing proper restoration of ligament natural tensioning, which could be well aided by computer-assisted surgical systems. Therefore the outcome of this replacement is, at present, mainly associated to surgeon's experience and visual inspection. In some of the current ankle prosthetic designs, tibial component positioning along the anterior/posterior (A/P) and medio/lateral axes is critical, particularly in those designs not with a flat articulation between the tibial and the meniscal or talar components. The general aim of this study was assessing in-vitro the effects of the A/P malpositioning of the tibial component on three-dimensional kinematics of the replaced joint and on tensioning of the calcaneofibular (CaFiL) and tibiocalcaneal (TiCaL) ligaments, during passive flexion. Particularly, the specific objective is to compare the intact ankle kinematics with that measured after prosthesis component implantation over a series of different positions of the tibial component.

Four fresh-frozen specimens from amputation were analysed before and after implantation of an original convex-tibia fully-congruent three-component design of ankle replacement (Box Ankle, Finsbury Orthopaedics, UK). Each specimen included the intact tibia, fibula and ankle joint complex, completed with entire joint capsule, ligaments, muscular structures and skin. The subtalar joint was fixed with a pin protruding from the calcaneus for isolating tibiotalar joint motion. A rig was used to move the ankle joint complex along its full range of flexion while applying minimum load, i.e. passive motion. In these conditions, motion at the ankle was constrained only by the articular surfaces and the ligaments. A stereofotogrammetric system for surgical navigation (Stryker-Leibinger, Freiburg, Germany) was used to track the movement of the talus/calcaneus and tibial segments, by using trackers instrumented with five active markers. Anatomical based kinematics was obtained after digitization by an instrumented pointer of a number of anatomical landmarks and by a standard joint convention. The central point of the attachment areas of CaFiL e TiCaL was also digitised. Passive motion and ankle joint neutral position were acquired, and the standard operative technique was performed to prepare the bones for prosthesis component implantation. The final component for the talus was implanted, the tibial component was initially positioned well in front of the nominal right (NR) position, the meniscal bearing was instrumented with an additional special tracker, and passive motion was collected again in passive flexion. Data collection was repeated for progressively more posterior locations for the tibial component, for a total of six different locations along the tibial A/P axis: three anterior (PA), the NR, and two more posterior (PP), approximately 3 to 5 mm far apart each. The following three-dimensional kinematics variables were analyzed: the three anatomical components of the ankle joint (talus-to-tibial) rotation (dorsi/plantar flexion, prono/supination and internal/external rotation respectively in the sagittal, frontal and transverse planes), the meniscal bearing pose with respect to the talar and tibial components, the ‘ligament effective length fraction’ as the ratio between the instantaneous distance between the ligament attachment points and the corresponding maximum distance, and the instantaneous and mean helical axes in the tibial anatomical reference frame.

In all specimens and in all conditions, physiological ranges of flexion, prono/supination and internal/external rotation were observed at the ankle joint. A good restoration of motion was observed at the replaced joint, demonstrated also by the coupling between axial rotation and flexion and the physiological location of the mean helical axis, in all specimens and in most of the component positions. Larger plantar- and smaller dorsi-flexion were observed when the tibial component was positioned more anteriorly than NR, and the opposite occurred for more posterior positions. In regards to the meniscal bearing, rotations were small and followed approximately the same patterns of the ankle rotations, accounted for the full conformity of the articulating surfaces. Translations in A/P were larger than in other directions, the bearing moving backward in plantarflexion and forward in dorsiflexion with respect to both components. It was observed that the closer to NR the position of the tibial component is, the larger this A/P motion is, accounted mainly to the associated larger range of flexion. The change of CaFiL and TiCaL effective length fraction over the flexion arc was found smaller than 0.1 in three specimens, smaller than 0.2 in the fourth, larger both in more anterior and more posterior locations of the tibial component. The simulated malpositioning did not affect much position and orientation of the mean helical axis in both the transversal and frontal planes.

The experimental protocol and measurements were appropriate to achieve the proposed goals. All kinematics variables support the conclusion that the ankle replaced with this original prosthesis behaves as predicted by the relevant computer models, i.e. physiological joint motion and ligament tension is experienced resulting in a considerable A/P motion of the meniscal bearing. These observations are particularly true in the NR postion for the prosthesis, but are somehow correct also in most of the tibial malpositions analysed, in particular those on the back.