Opening-wedge High Tibial Osteotomy (HTO) has been shown to be an effective procedure to treat mild to moderate osteoarthritis of the medial compartment of the knee in active individuals. It has also become a mandatory surgical adjunct to articular cartilage restoration when there is preoperative mal-alignment. However, its efficacy is directly correlated with the accuracy of the correction, which must be within 3° of the preoperative target. Achieving this goal is a significant challenge with conventional techniques. Therefore, computer-assisted navigation protocols have been developed; however, they do not adequately address the technical difficulties associated with this procedure. We present an integrated solution dedicated to the opening-wedge HTO. Advantages to the technique we propose include: 1) a minimum number of implanted bone trackers, 2) depth control of the saw, 3) improved 3-D accuracy in the location of the lateral tibial hinge, and 4) micrometric adjustment of the degree of correction. The proof of concept has been completed on all six specimens. The following key points have been validated: a) Compatibility with a minimally-invasive (5–6 cm) surgical incision b) The compact navigation station can be placed close to the operative field and manipulated through a sterile draping device c) Only two trackers are necessary to acquire the required landmarks and to provide 3-D control of the correction. These can be inserted within the surgical wound without any secondary incisions d) The optimised guide accurately controlled the external tibial hinge in all six cases e) The implant cavity could be milled effectively f) The distractor used to complete the desired realignment maintained stability of the distraction until final fixation with the PEEK implant g) The PEEK implant could be fixed to the tibia with excellent stability in a low-profile fashion. The solution presented here has the potential to help surgeons perform a medial opening-wedge HTO more safely and accurately. This will likely result in an increase in the number of HTOs performed for both isolated medial compartment osteoarthritis as well as for lower extremity realignment in association with cartilage restorative procedures.

Soft tissue gaps created in total knee replacement rely on the creation of symmetrical spaces that accommodate prosthetic implants. We studied a new custom surface registration protocol in a computer navigation system to accurately and precisely measure these gaps. In eight cadaver lower extremities, gaps were measured from the proximal tibial cut surface to the registered most distal surfaces of the medial and lateral femoral condyles, measured from 0 to 120 degrees. The computer measurement was compared against metrology spacers precise to 200 microns. Tensor reproducibility was assessed using a typical teeter-toter tensor in four specimens with cruciate retained and four with sacrificing technique.

Generalised MANOVA tests were used for assessment of means of repeated measures involving the three separate experiments. There was no difference between the measurements obtained using computer navigation compared to the metrology spacers in one specimen including the re-registration group (P = NS, Beta = 0.9). The sagittal position of the knee (Flexion/Extension) did affect the magnitude of the measurements obtained. (P=.001) For comparison, descriptive statistics of spacer block versus navigation measure revealed for the medial compartment measurement, a mean (n=200) of 0.006 mm (SD: 0.32 mm) and lateral compartment measure (n=200) of 0.12 mm (SD: 0.41 mm). The projected maximum error was 1.0 mm capturing 100% of values to 90 degrees. The re-registration repeated measures experiment varied as a function of knee flexion and the repetition number. Descriptive statistics for comparison revealed a mean medial compartment measure (n=200) of 0.24 mm (SD: 0.54 mm) and lateral compartment measure(n=200) of 0.01 mm(SD: 0.42 mm).

The tensor study compared the ability of the surgeon to produce a consistent gap measure over eight separate trials. Hypothesis testing revealed significant differences as a function of degree of flexion, order of testing (with later tests having greater gaps), and the specimen being measured (P<.001, P<.001, and P<.001).

The overall conclusion of the block studies was that the computer system was accurate to at least one millimeter for measuring the gaps of the knee. The tensor study demonstrated stretching or permanent strain of the ligaments, significant differences between the angles of flexion and between the individual specimens. This is to say that each specimen was unique with variability of measurements through the range of motion.

In TKA, prosthetic femoral and tibial implants must be symmetrically placed and matched in the mechanical axis and the ligament gaps must be correctly balanced. The collateral ligaments are the key guide, as they arise from the epicondyles of the distal femur, are perpendicular to the AP axis of Whiteside, and are coincident with the transtibial axis of the proximal tibial surface. A perpendicular bisection of the transtibial axis creates the AP axis of the tibia which is coincident in space with the AP axis of Whiteside (Berger). Measured distal femoral resection targets including TEA, AP axis of Whiteside, and 3 degrees external to the posterior condylar axis works because the stout posterior cruciate ligament limits laxity in flexion, allowing for the anatomical variation of these landmarks to be accommodated. The Insall, Ranawat gap balancing methods work to balance the knee in flexion, often matching the results of a measured resection, but guaranteeing a symmetrically balanced flexion gap. Distal femoral internal rotation can result if the medial collateral is over-released, but experience has shown this not to be a problem if the gaps are well balanced. Tibial tray position must be placed coincident with the AP axis of the tibia, which also is coincident with Akagi's line (line from medial margin of patellar tendon to center of the posterior cruciate ligament). The surgeon can make a line from the AP axis of Whiteside to the anterior tibial which matches the AP tibial axis.

Major aspects on long-term outcome in Total Knee Arthroplasty are the correct alignment of the implant with the mechanical load axis, the rotational alignment of the components as well as good soft tissue balancing. To reduce the variability of implant alignment and at the same time minimise the invasiveness different computer assisted systems have been introduced.

To achieve accuracy as high as those of a robotic system but with a pure mechanically adjustable cutting block, the Exactech GPS system has been developed. The new concept comprises a seamlessly planning and navigation screen with an integrated optical tracking system for fast and accurate acquisition and verification of anatomical landmarks within the sterile field as well as a tiny cutting guide for accurate transfer of the planned bone resections.

Using a conventional screwdriver the cutting block could be accurately aligned with the planned resection by controlling the current position of the cutting block on the navigation screen. To save time, to maximise the ease of use and to minimize the surgeon's mental workload during adjustment, a smart screwdriver (SSD) has been developed being able to automatically adjust the screws.

The basic idea of the smart screwdriver is to have a system providing an automatic transfer of the planned data to the cutting guide similar to a robotic system, but with the actuators separated from the kinematic. The use of the SSD is as simple as follows: After planning of the intervention and rigid fixation of the cutting guide on the bone, the surgeon simply connects sequentially the screwdriver to all screws of the cutting guide.

To further maximise the ease of use and to avoid a mix-up of different screws, an identification means has been integrated into the positioning screws as well as into the smart screwdriver. For an automated identification of the screws different technologies have been analysed as position tracking, optical recognition or wired/wireless electronics.

A first prototype without screw identification has been used successfully on 4 cadaver knees. All guide positions could be adjusted automatically using the SSD. However, the absence of screw identification required that the surgeon follows indications given by the computer to turn screws sequentially.

A second prototype of the smart screwdriver has successfully been built up and is able to identify the different positioning screws in less than 1s with high reliability. The identification is realised as inductive coupling of different small resonance circuits that are integrated into the screw heads and the screwdrivers tip.

To adjust the cutting guide from neutral to the planned position, the screws have to be adjusted by 5 mm in average. The rotational speed of the current SSD implementation is 2 rounds per second, resulting in a mean time of about 3.5 s for each screw adjustment. The rotational accuracy of the screwdriver is ±5°. Taking into account a thread of the positioning screws of 0.7 mm, the theoretical translational error is about ±0.01 mm. Looking at the angular accuracy, the maximum distance of the screws of the current setup of the cutting block of 15 mm results in an angular error of less than ±0.05°.