Evidence map›Paper›PMID 30832636›Full record

Observational studyBMC musculoskeletal disorders2019

Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up.

N M C Mathijssen, H Verburg, N J London, M Landsiedl, M Dominkus

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02337244 active not recruitingnot on this map

Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)

TypeobservationalSponsorZimmer, GmbHRan2013 to 2026Enrolled777ConditionsSevere Knee Pain, Severe Knee Disability, Osteoarthritis, Rheumatoid ArthritisArmsZimmer Persona Total Knee System
NCT06507046 narecruitingnot on this mapstarted 2024, after this paper: background citation

Robotic Assisted Surgery Comparing Personalized Alignment Versus Mechanical Alignment of Total Knee Arthroplasty - A Randomized Controlled Trial

TypeinterventionalSponsorHelse Møre og Romsdal HFRan2024 to 2035Enrolled152ConditionsKnee OsteoarthritisArmsTotal knee replacement
3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

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  10. Mid-term results of an anatomic total knee replacement design.Archives of orthopaedic and trauma surgery · 2024
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  13. Long-term outcomes of the NexgenEuropean journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

N M C Mathijssen, Department of Orthopedics, Reinier de Graaf Hospital, Reinier de Graafweg 5, 2625AD, Delft, The Netherlands. N.Mathijssen@rdgg.nl.ORCID http://orcid.org/0000-0002-4368-5463
H Verburg, Department of Orthopedics, Reinier de Graaf Hospital, Reinier de Graafweg 5, 2625AD, Delft, The Netherlands.
N J LondonDepartment of Orthopaedics, Harrogate and District Foundation Trust, Park Rd, Harrogate, Lancaster, HG2 7SX, UK.
M Landsiedl, Department of Orthopedics, Orthopaedic Hospital Speising, Speisinger Str. 109, 1130, Vienna, Austria.
M Dominkus, Department of Orthopedics, Orthopaedic Hospital Speising, Speisinger Str. 109, 1130, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMore 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.

methodsFrom 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.

resultsA 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.

conclusionThe 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 registrationClinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.

Indexed as

Patient Reported Outcome MeasuresAgedArthroplasty, Replacement, KneeCohort StudiesFemaleFollow-Up StudiesHumansKnee ProsthesisMaleMiddle AgedPostoperative CareProspective StudiesTime FactorsOsteoarthritisPatient reported outcomesTotal knee arthroplasty

Identifiers

PMID30832636
PMCPMC6399845

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.