Higher satisfaction and function scores in restricted kinematic alignment versus mechanical alignment with medial pivot design total knee arthroplasty: A prospective randomised controlled trial

Abstract Purpose Restricted kinematic alignment (rKA) in total knee arthroplasty (TKA) and medial pivot (MP) knee designs already showed superior outcomes in independent comparative studies. The objective of this study was to assess whether rKA with MP TKA provides better clinical and functional outcomes compared to mechanical alignment (MA) with MP TKA. Methods This is a randomised, parallel two group study involving a total of 98 patients with end‐stage knee osteoarthritis. Patients were randomly allocated to either rKA or MA TKA procedures conducted with a MP prothesis using patient‐specific instruments between 2017 and 2020. Final follow‐up was at 2 years postoperatively. Demographic data and clinical and functional scores (Oxford knee score, knee society score [KSS], Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], forgotten joint score [FJS]) were collected and compared preoperative, 1 year postoperative and 2 years postoperative. Coronal plane alignment of the knee and functional knee phenotype classification were recorded. Results A total of 47 patients (rKA) and 51 patients (MA) were included in final analysis. Superior joint awareness scores (FJS) were found at 1 year postoperative for rKA (62.2 vs. 52.4, p = 0.04). KSS subscores (expectation score, satisfaction score) improved with rKA with significant differences at both 1 and 2 years postoperatively. Major differences between rKA and MA were found in subgroup analysis of varus and neutral CPAK phenotypes. Both 1 year and 2 years postoperatively, FJS was significantly better in KA compared with MA in varus CPAK phenotypes (63.1 vs. 44.9, p = 0.03; 71.1 vs. 46.0, p = 0.005). Further clinical and functional scores showed improvement in the varus CPAK phenotypes with predominantly significant improvement in the expectation and satisfaction KSS subscores. No significant differences were found in the comparison of rKA and MA in neutral CPAK phenotypes. Conclusion The rKA of MP TKA design shows superior patient satisfaction and self‐reported function when compared to MA MP TKA. Furthermore, rKA MP TKA shows superior joint awareness at early postoperative stage. The most important clinical relevance of this study is the clear superiority of rKA in varus phenotypes. Level of Evidence Level II.