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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 56 - 56
1 Feb 2021
Catani F Illuminati A Ensini A Zambianchi F Bazzan G
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Introduction

Robotics have been applied to total knee arthroplasty (TKA) to improve surgical precision in component placement and joint function restoration. The purpose of this study was to evaluate prosthetic component alignment in robotic arm-assisted (RA)-TKA performed with functional alignment and intraoperative fine-tuning, aiming for symmetric medial and lateral gaps in flexion/extension. It was hypothesized that functionally aligned RA-TKA the femoral and tibial cuts would be performed in line with the preoperative joint line orientation.

Methods

Between September 2018 and January 2020, 81 RA cruciate retaining (CR) and posterior stabilized (PS) TKAs were performed at a single center. Preoperative radiographs were obtained, and measures were performed according to Paley's. Preoperatively, cuts were planned based on radiographic epiphyseal anatomies and respecting ±3° boundaries from neutral coronal alignment. Intraoperatively, the tibial and femoral cuts were modified based on the individual soft tissue-guided fine-tuning, aiming for symmetric medial and lateral gaps in flexion/extension. Robotic data were recorded.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 73 - 73
1 Feb 2020
Catani F Ensini A Zambianchi F Illuminati A Matveitchouk N
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Introduction

Robotics have been applied to total knee arthroplasty (TKA) to improve surgical precision in components’ placement, providing a physiologic ligament tensioning throughout knee range of motion. The purpose of the present study is to evaluate femoral and tibial components’ positioning in robotic-assisted TKA after fine-tuning according to soft tissue tensioning, aiming symmetric and balanced medial and lateral gaps in flexion/extension.

Materials and Methods

Forty-three consecutive patients undergoing robotic-assisted TKA between November 2017 and November 2018 were included. Pre-operative radiographs were performed and measured according to Paley's. The tibial and femoral cuts were performed based on the individual intra-operative fine-tuning, checking for components’ size and placement, aiming symmetric medial and lateral gaps in flexion/extension. Cuts were adapted to radiographic epiphyseal anatomy and respecting ±2° boundaries from neutral coronal alignment. Robotic data were recorded, collecting information relative to medial and lateral gaps in flexion and extension.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 7 - 7
1 Oct 2019
Catani F Ensini A Zambianchi F Illuminati A Matveitchouk N
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Introduction

Robotic technology has been applied to unicompartmental knee arthroplasty (UKA) in order to improve surgical precision in prosthetic component placement, restore knee anatomic surfaces, and provide a more physiologic ligament tensioning throughout the knee range of motion. Recent literature has demonstrated high reliability of robotic-arm assisted UKA in component placement and executing a soft-tissue tensioning plan, with excellent short-term survivorship. Few studies have investigated survivorship and patients' satisfaction at longer follow-ups. Therefore, the purpose of the present study was to determine the survivorship, clinical results and patients' satisfaction of robotic-arm assisted UKAs at a mid-term follow-up, with a minimum of 5 years of follow-up.

Methods

The present retrospective study includes 252 patients (260 knees) who underwent robotic-arm assisted fixed bearing metal backed UKAs at a single centre between April 2011 and July 2013. The mean age at surgery was 66.2 years (SD 8.6). Post-operatively, patients were administered the Forgotten Joint Score-12 (FJS) and asked about their satisfaction level after knee surgery (grade from 1 to 5). Post-operative complications were recorded. Failure mechanisms, revisions and reoperations were also assessed. Kaplan-Meier survival curves were calculated, considering reoperation for all causes and revision as the events of interest.


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 435 - 442
1 Apr 2019
Zambianchi F Franceschi G Rivi E Banchelli F Marcovigi A Nardacchione R Ensini A Catani F

Aims

The purpose of this multicentre observational study was to investigate the association between intraoperative component positioning and soft-tissue balancing on short-term clinical outcomes in patients undergoing robotic-arm assisted unicompartmental knee arthroplasty (UKA).

Patients and Methods

Between 2013 and 2016, 363 patients (395 knees) underwent robotic-arm assisted UKAs at two centres. Pre- and postoperatively, patients were administered Knee Injury and Osteoarthritis Score (KOOS) and Forgotten Joint Score-12 (FJS-12). Results were stratified as “good” and “bad” if KOOS/FJS-12 were more than or equal to 80. Intraoperative, post-implantation robotic data relative to CT-based components placement were collected and classified. Postoperative complications were recorded.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 5 - 5
1 Mar 2017
Siegler S Belvedere C Toy J Ensini A Leardini A
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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.

Methodology

The study was conducted on ten cadaver ankle specimens. Image processing software (Analyze DirectTM) was used to obtain 3D renderings of the articulating bones. The 3D bone models were then introduced into engineering design software packages (, GeomagicTM and InventorTM) to produce a set of four custom-fit virtual articular surfaces for each specimen: 1. Exact replica of the natural surfaces; 2. cylindrical; 3. truncated cone with apex oriented medially according to Inman's postulate; and 4. SSCL. The virtual TAR implants were exported to a 3D printing software and 3D physical models of each implant was produced in PLA using 3D printing (Figure 1). The intact cadaver was tested first in a specially design loading and measuring system [3] in which external moments were applied across the ankle in the three planes of motion and the resulting motion was measured through a surgical navigation system (Figure 1). Each of the four customized implant sets were then surgically introduced one at a time and the test was repeated. From the results, the ankle, subtalar and complex kinematics could be compared to that of the intact natural joint.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 56 - 56
1 Jan 2017
Belvedere C Ensini A Tamarri S Ortolani M Leardini A
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 12 - 12
1 Jan 2017
Belvedere C Siegler S Ensini A Caravaggi P Durante S Leardini A
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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.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_16 | Pages 24 - 24
1 Oct 2014
Leardini A Ensini A Belvedere C Tamarri S Barbadoro P d'Amato M Giannini S
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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.

PATIENT AND METHODS

Twenty patients recruited for TKA were implanted with Triathlon® prosthesis (Stryker®-Orthopaedics, Mahwah, NJ-USA). Seventeen patients, eleven operated targeting MA using the convention instrumentation (group A) and six targeting KA (group B) using PSI (Stryker®-Orthopaedics), were assessed at 6 month follow-up clinically via IKSS and biomechanically. Knee kinematics during stair-climbing, chair-rising, and extension-against-gravity were evaluated using three-dimensional mono-planar video-fluoroscopy (CAT® Medical-System, Monterotondo, Italy) synchronised with electromyography (Wave-Wireless, Cometa®, Milan, Italy). Component pose was reconstructed to calculate knee flexion/extension (FE), ad/abduction (AA), internal/external-rotation (IE), together with the rotation of the contact-line (CLR), i.e. line connecting the medial (MCP) and lateral (LCP) tibio-femoral contact points. MCP and LCP antero-posterior translations were calculated and reported in percentage (%) of the tibial base-plate length.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 94 - 94
1 Aug 2013
Belvedere C Ensini A Leardini A Dedda V Cenni F Feliciangeli A De La Barrera JM Giannini S
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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.

MATERIALS AND METHODS

Twenty patients with knee gonarthrosis were divided in two cohorts of ten subjects each and implanted with as many fixed-bearing posterior-stabilised prostheses (NRG® and Triathlon®, Stryker®-Orthopaedics, Mahwah, NJ-USA) with patellar resurfacing. Fifteen patients were implanted; five patients of the Triathlon cohort are awaiting hospital admission. TKAs were performed using two SNS (Stryker®-Leibinger, Freiburg-Germany). In addition to the traditional knee SNS (KSNS), the novel procedure implies the use of the patellar SNS (PSNS) equipped with a specially-designed patellar tracker.

Standard navigated procedures for intact TFJ survey were performed using KSNS. These were performed also with PSNS together intact PFJ survey. Standard navigated procedures for TFJ implantation were performed using KSNS. During patellar resurfacing, the patellar cutting jig was fixed at the desired position with a plane probe into the saw-blade slot; PSNS captured tracker data to calculate bone cut level/orientation. After sawing, resection accuracy was assessed using a plane probe. TFJ/PFJ kinematics were captured with all three trial components in place for possible adjustments, and after final component cementing. A calliper and pre/post-TKA X-rays were used to check for patellar thickness/alignment.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 95 - 95
1 Aug 2013
Ensini A Leardini A d'Amato M Fusai F Belvedere C Barbadoro P Timoncini A Giannini S
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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.

PATIENTS AND METHODS

A four-centre randomised study on 144 patients has been designed to assess these three techniques. In each centre, 36 patients are planned to be operated, 12 per technique. Currently, in our centre 18 patients have been operated so far: 6 via NOLA-CON (Group A), 3 via NOLA-PSI (Group B), and 9 via KOLA-PSI (Group C). All patients were implanted with a cruciate-retaining TKA (Triathlon®, Stryker®-Orthopaedics, Mahwah, NJ-USA) with patella resurfacing, those in PSI groups according to Otismed® imaging protocol. This includes pre-operative MRI scans at the hip, knee and ankle joints. Clinical evaluations were performed pre-operatively, at 45 days, and 3, 6 and 12 months post-operatively using the knee and functional IKSS (International Knee Society Score). At 45 days post-operatively a weight-bearing long leg radiograph was performed to measure possible differences between planned and implanted component alignment in patients operated via NOLA groups (A and B) and via KOLA group (C).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 267 - 267
1 Mar 2013
Boschert H de la Barrera JLM Belvedere C Ensini A Leardini A Giannini S
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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.

METHODS

These measurements were taken in the first ten patients, affected by primary gonarthrosis and implanted with a resurfacing posterior-stabilised prosthesis in the period July 2010 – May 2011. A standard knee navigation system was enhanced by a specially-designed patellar tracker, mounted with a cluster of three light emitting diodes. Standard procedures for femoral and tibial bone preparation were performed according to the navigation system, and the patellar was resurfaced. Relevant resection planes were taken by an instrumented verification probe. Final position of the three components and lower limb alignment were also acquired. Joint kinematics was deduced from the anatomical survey, which included anatomical landmarks on the patellar posterior aspect, and according to established recommendations and original proposals.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 83 - 83
1 Oct 2012
Belvedere C Ensini A Notarangelo D Tamarri S Feliciangeli A Leardini A
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 66 - 66
1 Oct 2012
Belvedere C Ensini A De La Barrera JM Feliciangeli A Leardini A Catani F
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 191 - 191
1 Sep 2012
Ensini A Timoncini A Belvedere C Cenni F Leardini A Giannini S
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Computer-assisted techniques in total knee replacement (TKR) have been introduced to improve bone cuts execution and relevant prosthesis components positioning. Although these have resulted in good surgical outcomes when compared to the conventional TKR technique, the surgical time increase and the use of additional invasive devices remain still critical. In order to cope with these issues, a new technology in TKR has been introduced also for positioning prosthetic components according to the natural lower-limb alignment. This technique is based on custom-fit cutting block derived from patient-specific lower-limb scan acquisition. The purpose of this study is to assess the accuracy of the custom-fit technology by means of a knee surgical navigation system, here used only as measurement system, and post-operative radiographic evaluations. Particularly, the performances of two different custom-fit cutting blocks realized from as many scan acquisitions have been here reported.

Thirty patients affected by primary knee osteoarthritis were enrolled in this study. Fifteen patients were implanted with GMK® (Medacta-International, Castel San Pietro, CH) and as many patients with Journey® (Smith&Nephew, London, UK). Both TKR designs were implanted by using custom-fit blocks for bone cut executions provided by the same TKR manufacturers according to a pre-operative web planning approved by the surgeon. Particularly, the cutting block for the former design was built from CT scan acquisition of the hip, knee and ankle, whereas that for the latter design from MRI scans acquisition of the knee and X-ray lower-limb overview. A knee surgical navigation system (Stryker®-Leibinger, Freiburg, Germany) was used for recording intra-operative alignment of bone cuts as performed by means of the custom-fit cutting blocks and relevant component positioning. Prosthetic components alignments were also assessed post-operatively on X-ray images according to a shape-matching technique. The accuracy of the custom-fit blocks was evaluated through the comparison between pre-operative planning, and intra/post-operative data. Discrepancies above 3° and millimeters were considered as outliers.

Within the patient cohort, nine cases were fully analyzed at the moment and here reported. Over them and except for one case, the discrepancy between pre-operative planned femoral/tibial resection level on the frontal plane and the corresponding measured intra-operatively was within 3 mm, being 5 mm in the worse case. Two outliers were observed for the corresponding femoral/tibial cut rotational alignment. Particularly, in one patient, the discrepancy in femoral cut alignment was of 8° in flexion and 6° in external rotation; in another patient this was of 4° in extension and 4° in external rotation in the femoral and tibial cut alignment, respectively. Post-operative radiographs evaluations for the final prosthetic components revealed that femoral/tibial alignment were within 3° in all cases, except for those patients that were already outliers.

These preliminary results reveal the efficacy of the custom-fit cutting block for TKR. These were generally fitted properly and final prosthetic components were accurately placed, although some discrepancies were observed. This new technology seems to be a valid alternative to conventional and computer-assisted techniques. More consistent conclusions can be deduced after final evaluation of all patients.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 124 - 124
1 Mar 2009
Catani F Ensini A Leardini A Bianchi L Giannini S
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Navigation-assisted surgery in total knee arthroplasty (TKA) is aimed at improving the accuracy with which prosthesis components are implanted in the bones, according to anatomical plane orientations. Traditional surgical techniques based on the identification of transepicondylar and intramedullary axes are replaced with those based on segmental anatomical frame definitions following anatomical landmark identification. These frames are offered on the screen to the surgeon to target in real time the alignment goal by adjusting position and orientation of the bone saw guides. However, immediately after sawing, final bone, and in case cement, preparation and component implantation is necessarily a series of actions performed manually by the surgeon. In the current study, we wanted to compare intra-operatively the final component alignments with the corresponding at the original resection planes.

In this series, 50 Scorpio PS TKAs were analyzed. The navigation system used was the Stryker Knee Navigation System (Stryker-Navigation, Kalamazoo, USA). An ‘anatomical survey’ defined anatomical frames for the femur and tibia, based on relevant anatomical landmark identification, and provided target orientations for all the relevant bone cuts. These references were targeted in all three anatomical planes, and bone cuts were made accordingly. Corresponding alignments of the bone resection planes in the frontal, sagittal and transverse planes for the femur and in the frontal and sagittal planes for the tibia were recorded, with a 0.5° resolution. Then, component implantation was performed and alignments were measured again by means of an instrumented probe. Because of the shape of the prosthesis components, only the alignments in the frontal plane for the femur and in the frontal and sagittal planes for the tibia were recorded.

The difference between the alignment of the bone cuts and the alignment of the prosthesis components, in the frontal plane of the femur, and in the frontal and sagittal planes of the tibia was larger than 2° respectively in 8%, 6%, 10% of the patients.

The present study offers a figure for the different alignment between resection planes and final implanted components, necessarily the effect of the manual procedures implied in TKA for the final implantation of the components. Considering that 1° is the claimed achievable accuracy of the navigation systems, and that the correct alignment goal was achieved at the resection planes, these figures reveal that in up to 10% of the patients the benefit obtained by navigation can be lost by the manual procedures implied in component implantation. These differences in alignment put also concerns in the postoperative statistical comparison between conventional and navigated TKAs.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 28 - 28
1 Mar 2006
Catani F Leardini A Belvedere C Ensini A Giannini S
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Patellar maltracking after total knee arthroplasy (TKA) introduces complications such as anterior knee pain and patellar subluxation, generally due to prosthetic component malallignment in both tibiofemoral (TF) and patellofemoral joints. It is still debated if it is necessary to resurface the patella, which would better adapt the patellar articular surface to the prosthetic femoral troclea with a prosthesis, but also result in possible bone fractures. In this study, an in-vitro analysis is presented in order to identify differences between intact and TKA patellar tracking with and without patellar resurfacing and to show how much the latter is similar to intact knee patellar tracking.

Three fresh-frozen amputated legs with knees free from anatomical defects and with intact joint capsule, collaterals and quadriceps tendon were analyzed using the Stryker knee navigation system (Kalamazoo, MI-USA). Landmark digitations were used to define anatomical frames for femur, tibia and patella. Manually driven TF flexions, from 0 to 140, were performed under conditions of no load and of 10 kg on the quadriceps, with intact knee and TKA with patella resurfaced and not. TF flex/extension, intra/extra rotation, ad/abduction were calculated according to a standard convention. Patellar flex/extension, medial/lateral tilt, rotation and shift were calculated according to a recently proposed articular convention.

Since more repeatable, results relative to trials under 10 kg are reported. Intact knee: 4 abduction; considerable intra rotation (from 16 to 4), followed by continuous extra rotation starting at 30 TF flexion; linear increase in patellar flexion (from 20 to 110); initial medial patellar rotation (from 12 to 8), followed by medial rotation starting at 60 TF flexion; initial lateral patellar tilt (from 4 lateral to 4 medial), followed by medial tilt starting at 70 TF flexion; initial 6 mm lateral patellar shifts from 0 to 80 TF flexion, followed by 4 mm medial shift. TKA knee: small differences in ad/abduction between intact and TKA knees, both with and without resurfaced patella; slight initial extra rotation, followed by continuous intra rotation starting at 20 TF flexion; linear increase in the flexion of the patella, both resurfaced and not, close to the that of the intact knee; patellar rotation more lateral than in the intact knee; patellar tilt without resurfaced patella closer to the intact knee one; 6 mm lateral patellar shift, likely accounted for the surgical technique.

Slightly more than TKA with resurfaced patella, TKA with non resurfaced patella flexes nearly like the intact knee. The closeness in values of patellar flexion and tilt represents a proof of the closeness in behavior of not resurfaced patella in TKA to the patella in the intact knee.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 89 - 89
1 Mar 2006
Catani F Fantozzi S Ensini A Leardini A Moschella D Giannini S
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Tibial component loosening continues to be the most common mode of TKA failure. A debate persists on the dependence of mobilisation of this component on the equilibrium between mechanical load transfer and counterbalancing bone resistance. The aim of the present work is to study the in-vivo kinematics of TKA and to relate it with the degree of posterior slope with which the tibial component was implanted for two prosthesis designs with congruent polyethylene insert.

Twenty-three patients with osteoarthritis of the knee had TKA using a cemented prosthesis (OPTETRAK, Exactech). A cruciate retaining (CR, 10 knees) or a posterior stabilized (PS, 13 knees) implant was randomly assigned at operation. Standard pre- and post-operative antero-posterior and lateral roentgenograms of the knee were taken. Fluoroscopic analysis was performed after at least 18 and 7 months after surgery for the CR and the PS group, respectively. Patients performed stair ascending, chair rising-sitting and step up-down motor tasks. Articular contacts were assumed as the two points on the medial and lateral femoral prosthetic condyles closest to the tibial component base-plate. The spine-cam distance was calculated as the minimum distance between corresponding surfaces.

Only small differences in the position of the contacts over knee flexion angles were found among the motor tasks and between the two TKA designs. An overall posterior location of the tibio-femoral contact points was found at the medial and lateral compartments over all motor tasks, a little more pronounced for the PS patients. Statistically significant correlation over the three motor tasks analysed was found between posterior position of the tibio-femoral medial contact in maximum knee flexion and the post-operative tibial posterior slope. This is true for the PS and for the aggregated groups. Although no statistically significant, a general trend is observed of higher degree of flexion at which the cam contacts the spine as the post-operative posterior slopes increases: a 35 higher knee flexion angle for a tibial component implanted with a 5 of posterior slope. Generally, even when the correlations were statistically significant the correlation coefficients were always lower than 0.4.

The present work reports combined measurements of post-operative posterior slope and full in-vivo relative motion of the components in both CR and PS TKAs. General trends were found between posterior slope of the tibial component and positions of the tibio-femoral contacts, but a statistically significant correlation was found only for the tibio-femoral medial contact in maximum knee flexion in the PS and in the aggregated. General trends were found between posterior slope of the tibial component and degree of flexion at which the cam starts to be in contact with the spine. The nearly standard antero-posterior translation of the tibio-femoral contacts can be bigger in flatter polyethylene inserts.