Improved Knee Function with Customized vs. Off-the-Shelf TKA Implants-Results of a Single-Surgeon, Single-Center, Single-Blinded Study

Background: Recent studies have been able to show certain benefits of Customized, Individually Made (CIM) compared to Off-the-Shelf (OTS) total knee arthroplasties (TKAs), but evidence is still lacking regarding the benefits of these implant systems. This study aimed to find differences in scores and functional outcome by comparing CIM and OTS implants, using Patient-Reported Outcome Measures (PROMs) and functional tests for activities of daily living in a single-surgeon setup. Methods: A total of 48 patients (16 CIM vs. 32 OTS) were consecutively enrolled and blindly examined. Functional testing was performed using four timed functional tests (TUG, WALK, TUDS, and BBS) and the VAS for pain. The Aggregated Locomotor Function (ALF) score was then calculated based on the addition of the average times of the three functional tests. Results: The CIM group showed significantly faster times in all functional tests and significantly better ALF scores. There were remarkable differences in the assessment of maximum pain sensation between the two groups, with superiority in the CIM group. The PROMs analysis revealed a higher proportion of excellent and good ratings for the items objective and function (KSS) in the CIM group. Conclusion: The study showed that time-limited activities of daily living (ADLs) can be completed significantly faster with a CIM prosthesis and that a significantly higher percentage in this group reports freedom from pain during certain loads. Partial aspects of the PROM scores are also better in this group; however, this superiority could not be shown with regard to most PROM scores collected in this study.