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.

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.