High tibial osteotomy (HTO) is an effective surgical treatment for isolated medial compartment knee osteoarthritis; however, widespread adoption is limited due to difficulty in achieving the planned correction, and patient dissatisfaction due to soft tissue irritation. A new HTO system – Tailored Osteotomy Knee Alignment (TOKA®, 3D Metal Printing Ltd, Bath, UK) could potentially address these barriers having a custom titanium plate and titanium surgical guides featuring a unique mechanism for precise osteotomy opening as well as saw cutting and drilling guides. The aim of this study was to assess the accuracy of this novel HTO system using cadaveric specimens; a preclinical testing stage ahead of first-in-human surgery according to the ‘IDEAL-D’ framework for device innovation. Local ethics committee approval was obtained. The novel opening wedge HTO procedure was performed on eight cadaver leg specimens. Whole lower limb CT scans pre- and post-operatively provided geometrical assessment quantifying the discrepancy between pre-planned and post-operative measurements for key variables: the gap opening angle and the patient specific surgical instrumentation positioning and rotation - assessed using the implanted plate. The average discrepancy between the pre-operative plan and the post-operative osteotomy correction angle was: 0.0 ± 0.2°. The R2 value for the regression correlation was 0.95. The average error in implant positioning was −0.4 ± 4.3 mm, −2.6 ± 3.4 mm and 3.1 ± 1.7° vertically, horizontally, and rotationally respectively. This novel HTO surgery has greater accuracy and smaller variability in correction angle achieved compared to that reported for conventional or other patient specific methods with published data available. This system could potentially improve the accuracy and reliability of osteotomy correction angles achieved surgically

Conventional TKA surgery attempts to restore patients to a neutral alignment, and devices are designed with this in mind. Neutral alignment may not be natural for many patients, and may cause dissatisfaction. To solve this, kinematical alignment (KA) attempts to restore the native pre-arthritic joint-line of the knee, with the goal of improving knee kinematics and therefore patient's function and satisfaction. Proper prosthetic trochlea alignment is important to prevent patella complications such as instability or loosening. However, available TKA components have been designed for mechanical implantation, and concerns remain relating the orientation of the prosthetic trochlea when implants are kinematically positioned. The goal of this study is to investigate how a currently available femoral component restores the native trochlear geometry of healthy knees when virtually placed in kinematic alignment. The healthy knee OAI (Osteoarthritis Initiative) MRI dataset was used. 36 MRI scans of healthy knees were segmented to produce models of the bone and cartilage surfaces of the distal femur. A set of commercially available femoral components was laser scanned. Custom 3D planning software aligned these components with the anatomical models: distal and posterior condyle surfaces of implants were coincident with distal and posterior condyle surfaces of the cartilage; the anterior flange of the implant sat on the anterior cortex; the largest implant that fitted with minimal overhang was used, performing ‘virtual surgery’ on healthy subjects. Software developed in-house fitted circles to the deepest points in the trochlear grooves of the implant and the cartilage. The centre of the cartilage trochlear circle was found and planes, rotated from horizontal (0%, approximately cutting through the proximal trochlea) through to vertical (100%, cutting through the distal trochlea) rotated around this, with the axis of rotation parallel to the flexion facet axis. These planes cut through the trochlea allowing comparison of cartilage and implant surfaces at 1 degree increments. Trochlear groove geometry was quantified with (1) groove radial distance from centre of rotation cylinder (2) medial facet radial distance (3) lateral facet radial distance and (4) sulcus angle, along the length of the trochlea. Data were normalised to the mean trochlear radius. The orientation of the groove was measured in the coronal and axial plane relative to the flexion facet axis. Inter- and intra-observer reliability was measured. In the coronal plane, the implant trochlear groove was oriented a mean of 8.7° more valgus (p<0.001) than the normal trochlea. The lateral facet was understuffed most at the proximal groove between 0–60% by a mean of 5.3 mm (p<0.001). The medial facet was understuffed by a mean of 4.4 mm between 0–60% (p<0.001). Despite attempts to design femoral components with a more anatomical trochlea, there is significant understuffing of the trochlea, which could lead to reduced extensor moment of the quadriceps and contribute to patient dissatisfaction