Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial).

INTRODUCTION: High tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig. METHODS AND ANALYSIS: A double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04000672; Pre-results.

Can accuracy of component alignment be improved with Oxford UKA Microplasty® instrumentation?

BACKGROUND: One factor in the long-term survivorship of unicompartmental knee arthroplasty is the accuracy of implantation. In addition to implant designs, the instrumentation has also evolved in the last three decades to improve the reproducibility of implant placement. There have been limited studies comparing mobile bearing unicompartmental knee arthroplasty with contemporary instrumentation and fixed bearing unicompartmental knee arthroplasty with conventional instrumentation. This study aims to determine whether the Microplasty instrumentation in Oxford unicompartmental knee arthroplasty allows the surgeon to implant the components more precisely and accurately. METHODS: A total of 150 patients (194 knees) were included between April 2013 and June 2019. Coronal and sagittal alignment of the tibial and femoral components was measured on postoperative radiographs. Component axial rotational alignment was measured on postoperative computer tomography. The knee rotation angle was the difference between the femoral and tibial axial rotation. A rotational mismatch was defined as a knee rotation angle of > 10°. Statistical analysis was performed using Student t test and Mann-Whitney nonparametric test. A p value < 0.05 was considered statistically significant in each analysis. RESULTS: Between April 2013 to June 2019, 112 patients (150 knees) received Oxford unicompartmental knee arthroplasty, one patient (2 knees) had Journey unicompartmental knee arthroplasty, and 37 patients (42 knees) received Zimmer unicompartmental knee arthroplasty. All femoral components in the Oxford group were implanted within the reference range, compared with 36.6% in the fixed bearing group (p < 0.001). 88.3% of Oxford knees had tibial component falling within the reference range, whereas 56.1% of knees in the fixed bearing group fell within the reference range (p < 0.001). 97.5% of Oxford knees had tibial slope that fell within reference range, whereas 53.7% fell within range for fixed bearing group (p < 0.001). Femorotibial rotational mismatch of more than 10° was noted in 13.8% in Oxford group and 20.5% in fixed bearing group (p = 0.04). CONCLUSION: In conclusion, Microplasty instrumentation for Oxford mobile bearing unicompartmental knee arthroplasty is more accurate and precise compared to conventional fixed bearing unicompartmental knee arthroplasty in sagittal, coronal, and axial alignment. Prospective studies with long-term follow-up are warranted to investigate the clinical implications.