Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up.
Osteoarthritis
Patient reported outcomes
Total knee arthroplasty
Journal
BMC musculoskeletal disorders
ISSN: 1471-2474
Titre abrégé: BMC Musculoskelet Disord
Pays: England
ID NLM: 100968565
Informations de publication
Date de publication:
04 Mar 2019
04 Mar 2019
Historique:
received:
29
10
2018
accepted:
18
02
2019
entrez:
6
3
2019
pubmed:
6
3
2019
medline:
20
6
2019
Statut:
epublish
Résumé
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. 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. 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. 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. Clinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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
BACKGROUND
Clinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.
Identifiants
pubmed: 30832636
doi: 10.1186/s12891-019-2470-y
pii: 10.1186/s12891-019-2470-y
pmc: PMC6399845
doi:
Banques de données
ClinicalTrials.gov
['NCT02337244']
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
97Références
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Clin Orthop Relat Res. 2009 Sep;467(9):2414-9
pubmed: 19343460
Pain. 2011 Mar;152(3):566-72
pubmed: 21239114
Clin Orthop Relat Res. 2012 Jan;470(1):20-32
pubmed: 22065240
J Bone Joint Surg Br. 2012 Mar;94(3):412-8
pubmed: 22371552
J Bone Joint Surg Br. 2012 Aug;94(8):1058-66
pubmed: 22844046
Am J Phys Med Rehabil. 2013 Oct;92(10):864-70
pubmed: 23900017
Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1933-9
pubmed: 24253376
Bone Joint J. 2014 Jul;96-B(7):928-35
pubmed: 24986947
Knee Surg Sports Traumatol Arthrosc. 2014 Dec;22(12):2911-23
pubmed: 25217314
J Clin Epidemiol. 2015 Jan;68(1):73-9
pubmed: 25441700
Knee. 2015 Sep;22(4):333-7
pubmed: 26003214
Bone Joint J. 2015 Nov;97-B(11):1493-500
pubmed: 26530651
J Arthroplasty. 2016 Apr;31(4):754-8
pubmed: 26654489
Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29
pubmed: 27012756
J Arthroplasty. 2017 Jan;32(1):87-91
pubmed: 27436502
J Arthroplasty. 2017 May;32(5):1426-1430
pubmed: 28034481
Acta Orthop. 2017 Apr;88(2):173-178
pubmed: 28056570
Clin Orthop Relat Res. 2017 Jul;475(7):1874-1886
pubmed: 28299718
Arthroplast Today. 2016 Aug 21;2(4):193-198
pubmed: 28326427
Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803
pubmed: 28801208
Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336
pubmed: 28808025
Am J Knee Surg. 1997 Fall;10(4):255-60
pubmed: 9421602
J Bone Joint Surg Br. 1998 Jan;80(1):63-9
pubmed: 9460955
J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96
pubmed: 9699158