No difference in patient-reported satisfaction after 12 months between customised individually made and off-the-shelf total knee arthroplasty

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Purpose</jats:title> <jats:p>A subset of patients is usually not satisfied after a total knee arthroplasty (TKA). Customised individually made (CIM) TKA are deemed to overcome drawbacks of classical off-the-shelf (OTS) TKA, but evidence is still sparse. The aim of this study was to compare satisfaction of patients with CIM and OTS TKA.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>This prospective cohort study compared clinical and patient-reported outcome measures (PROM) between patients with CIM and OTS TKA. The primary outcome was patient satisfaction after 12 months. Secondary outcomes were the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Forgotten Joint Score (FJS-12) and the EQ-5D-3L after 4 and 12 months.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>Data were analysed from 74 CIM TKA and 169 OTS TKA between January 2017 and September 2020. Patients with CIM TKA were slightly younger, more often male, had a lower body mass index, a lower KSS and partially higher preoperative PROMs.</jats:p> <jats:p>Patient satisfaction after 12 months was high and comparable (CIM 87%, OTS 89%). All PROMs improved for both groups (<jats:italic>p</jats:italic> < 0.001) and did not differ after 12 months (<jats:italic>p</jats:italic> > 0.063). The majority of patients improved above the minimal important difference (range 65 to 89%) and reported a clear overall improvement (CIM 86%, OTS 87%). The postoperative KSS, notably regarding knee stability, was higher for CIM TKA (<jats:italic>p</jats:italic> < 0.001).</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>No difference was found in patient satisfaction between CIM and OTS TKA after 12 months. In both groups, patient satisfaction was high and PROMs improved considerably.</jats:p> </jats:sec><jats:sec> <jats:title>Level of evidence</jats:title> <jats:p>II, prospective cohort study.</jats:p> </jats:sec>