While patient-specific instrumentation (PSI) in total knee arthroplasty (TKA) allows for transfer of the preoperative plan onto bony landmarks, the soft tissue balancing is not affected. The goals of this randomized clinical trial were to compare PSI and the measured resection technique (conventional) with PSI and the gap balancing technique. Fifty patients were randomized to TKA with conventional PSI (PSI-S) (n = 25) or to PSI with additional gap balancing (PSI-GB) (n = 25). All patients were clinically examined at 3 and 12 months postoperatively. Data on the range of motion, the Knee Society Score, the Western Ontario and McMasters Universities Osteoarthritis Index, the High-Flexion Knee Score (HFKS), and the Forgotten Joint Score (FJS) were compiled at follow-up. Statistically significant improvements were found for all clinical parameters in the PSI-GB group compared to the PSI-S group at 3 months postoperatively and for FS, FJS, and HFKS at 12 months. However, the relevance of these differences, as well as their effect on long-term outcomes, needs to be evaluated further. In conclusion, patient-specific instrumentation combined with gap balancing yielded good early clinical outcomes.
Total knee arthroplasty Patient-specific instrumentation Gap balancing Extension-first technique Randomized clinical trial
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This study was funded by Smith & Nephew GmbH, Hamburg, Germany. The sponsor had no involvement in the writing of the report or in the decision to submit the results for publication.
Compliance with ethical standards
The study complies with the current laws of the country in which it was performed.
Conflict of interest
Hagen Hommel has received research grants from Smith & Nephew, has received a speaker honorarium from Smith & Nephew during the conduct of the study, and has received a speaker honorarium from Smith & Nephew, DePuy and Aesculap, outside the submitted work. Matthew P. Abdel declares that he has no conflict of interest. Carsten Perka has received a speaker honorarium from DePuy, Smith & Nephew, Zimmer Biomet, Aesculap, outside the submitted work.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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