Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up.
BMC Musculoskelet Disord
; 20(1): 97, 2019 Mar 04.
Article
em En
| MEDLINE
| ID: mdl-30832636
ABSTRACT
BACKGROUND:
More personalized implant designs for total knee arthroplasty might optimize the clinical outcome after surgery. One of these personalized implant designs is the Persona knee implant system (Zimmer Biomet, Warsaw, Indiana, USA). The primary objective of this study was to determine patient reported outcomes and implant survivorship of the Persona Knee system used in primary total knee arthroplasty, up to two years after surgery.METHODS:
From November 2013 to July 2016 consecutive patients undergoing primary total knee arthroplasty were enrolled in a prospective observational cohort study at three centers. Preoperatively, at 6 weeks, 6 months, 1 and 2 years after surgery, patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), the Knee Society Score (KSS, 2011, modified version) and the EQ-5D. Adverse Events were captured, assessed for relationship to device, and recorded in the study database. Furthermore, physical functioning was assessed by the orthopedic surgeon. Repeated measures analyses were performed on PROM scores. Kaplan Meier was used to calculate survivorship of the Persona Knee Implant System.RESULTS:
A total of 146 total knee arthroplasties were performed. 61% (89/146) of the patients were female and mean age was 64.7 (± 6.9) years. Two years after surgery, one patient had a revision of the polyethylene insert because of a periprosthetic joint infection. Therefore, the Kaplan-Meier survival estimate at 2 years was 0.99 (0.95-1.00 95% CI). OKS increased from 22.1 (95% CI 20.9-23.3) to 41.8 (95% CI 40.6-43.1) two years after surgery. Furthermore, all other PROMs also increased from before surgery to 2 year postoperatively.CONCLUSION:
The Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good; pain, function and quality of life all improved greatly after TKA. Further studies are needed to determine the long term clinical performance of the Persona prosthesis. TRIAL REGISTRATION Clinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cuidados Pós-Operatórios
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Artroplastia do Joelho
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Medidas de Resultados Relatados pelo Paciente
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Prótese do Joelho
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
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Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
BMC Musculoskelet Disord
Assunto da revista:
FISIOLOGIA
/
ORTOPEDIA
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Holanda