Abstract
Purpose
The primary aim of this study was to report the early clinical and radiographic outcomes of patients who have been treated with total knee arthroplasty (TKA) using the Persona knee system. The secondary aim was to compare patient-reported outcomes (PROs) of the Persona knee system to those of the NexGen implant.
Methods
A registry-based study of a consecutive series of 112 patients (129 knees) treated with the Persona knee system from a single center was conducted. Preoperative, 1-year, and 2-year radiographs and PROs were analyzed. Postoperative radiographs were assessed for radiolucency and component positioning. Patients were monitored for postoperative complications and revision. Two-year PROs were compared to a 1:1 propensity score-matched cohort of patients treated with the NexGen knee system.
Results
Ninety-five percent of knees were within literature-defined safe ranges of the anatomical tibiofemoral axis, tibial varus/valgus angle, femoral flexion/extension angle, and tibial slope. Radiolucency was observed in 0.9% and 1.3% of knees at one and 2 years, respectively. Two-year PRO values demonstrated clinically meaningful improvements from the preoperative values. The cumulative 2-year percent revision was 3.0% (95% confidence interval 1.9–3.8%); there were no revisions due to implant mechanical failure. Patients treated with the Persona knee system had higher KOOS symptom (p = 0.037) and KOOS QOL (p < 0.001) scores compared to patients with the NexGen knee system.
Conclusions
This knee design demonstrates excellent clinical outcomes, similar or better than the NexGen knee system, at early follow-up.
Level of evidence
III.
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Funding
This study was supported by the Harris Orthopaedic Laboratory (HOL), Massachusetts General Hospital, Boston, Massachusetts and ZimmerBiomet, Warsaw, Indiana. The institutions and ZimmerBiomet signed a standard legal study agreement. The agreement stated that the economic support was granted unconditionally and that the manufacturer would have no influence on study design, data analysis or publication.
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VPG, MAB, RM, CSN, and CB declare that they have no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of Massachusetts General Hospital (approval #: 2014P002678) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Galea, V.P., Botros, M.A., Madanat, R. et al. Promising early outcomes of a novel anatomic knee system. Knee Surg Sports Traumatol Arthrosc 27, 1067–1074 (2019). https://doi.org/10.1007/s00167-018-5248-0
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DOI: https://doi.org/10.1007/s00167-018-5248-0