Custom TKA combined with personalised coronal alignment yield improvements that exceed KSS substantial clinical benefits.

PURPOSE: The purpose of this study was to report Knee Society Scores (KSS) at 12-month follow-up in a series of 266 knees that received custom TKA. The hypothesis was that custom TKA combined with personalised alignment would yield improvements greater than substantial clinical benefits (SCB) of KSS Knee and Function. METHODS: From a consecutive series of 905 patients (918 knees) that received primary TKAs, 261 (29%) patients (266 knees) received computed tomography (CT)-based posterior-stabilised cemented custom TKA. Knees were aligned aiming to preserve or restore constitutional alignment within predetermined limits of 85°-95° for femoral mechanical angle (FMA) and tibial mechanical angle (TMA), and 175°-183° for hip knee ankle (HKA) angle. The KSS Knee and Function were collected preoperatively and 12 months postoperatively, to determine if patients achieved SCB. Uni- and multivariable analyses were performed to determine associations between KSS scores (Knee and Function) and patient demographics as well as pre- and postoperative radiographic alignments. RESULTS: Of the initial cohort of 261 patients, 4 (1.8%) were reoperated for patellar resurfacing, 1 (0.4%) for lavage to treat infection, and 1 (0.4%) had arthroscopy to treat a stiff knee with < 90° range of motion. Complete clinical records were available for 227 patients (232 knees, 87%) that comprised 102 men (5 bilateral) and 125 women. At 12-month follow-up, mean improvements in KSS Knee and Function scores were, respectively, 61.0 ± 13.0 and 42.7 ± 16.7, which exceeded the SCB of KSS. Comparison of knees inside versus outside the target zone revealed no differences in KSS Knee (94.1 ± 9.1 versus 94.3 ± 9.0, n.s.) and Function (96.1 ± 9.2 versus 96.3 ± 8.9, n.s.). Multivariable analysis revealed worse KSS Knee in knees with preoperative FMA > 95° (ß = - 6.21; p = 0.023), but no association between KSS Function and patient demographics or pre- and postoperative radiographic alignments. CONCLUSIONS: Custom TKA combined with personalised alignment yielded improvements that exceeded substantial clinical benefits of KSS Knee and Function scores. These findings demonstrate the feasibility of custom TKA with 'personalised alignment' and encourage further investigations using comparative studies at longer follow-up. LEVEL OF EVIDENCE: IV, case series.