Persona Revision Knee System EMEA PMCF Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer, GmbH
About this trial
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient qualifies for a revision knee arthroplasty with the Persona Revision Knee System. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
One-stage revision performed for infection OR
Second stage (reimplantation) of a planned two-stage revision.
Patient is ≥ 18 years.
Disqualifiers
Patient received the study device for any condition not listed in the indications or in combination with a non-compatible device.
First Knee Replacement patients.
Patient with only inlay/bearing exchange/revision.
Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
Trial population
Patients undergoing revision total knee arthroplasty with the Persona Revision Knee System who meet the study eligibility criteria at participating study sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
238 Participants
are grouped into 2 trial groupsGroup A: Cohort 1: Persona Revision Knee + CCK articular surface
Group B: Cohort 2: Persona Revision Knee + CPS or PS articular surface
Trial outcomes
Primary outcomes
1
Change in Oxford Knee Score (OKS) from Baseline to 2 Years
Average change in Oxford Knee Score (OKS) from baseline to 2 years follow-up. The average change will be evaluated against the Minimal Clinically Important Difference (MCID) of 4.0 points.
Time frame
From baseline (pre-operative assessment) to 2 years after surgerySecondary outcomes
1
All-Cause Implant Survival
All-cause survival of the implant system based on removal of any core system component (femoral component, tibial plate, or articular surface) for any reason
Time frame
From surgery up to 10 years post-surgery2
Adverse events / Safety
Safety of the Persona Revision Knee System assessed by the frequency and incidence of adverse events, including the relationship of events to the implant, instrumentation, and/or surgical procedure.
Time frame
From surgery up to 10 years of follow-up3
Oxford Knee Score - follow-up beyond the primary endpoint
Oxford Knee Score to assess knee pain and functional performance during follow-up. The Oxford Knee Score ranges from 0 to 48, with higher scores indicating better outcomes.
Time frame
Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery4
EQ-5D-5L Health Related Quality of Life
EQ-5D-5L to assess subject health-related quality of life during follow-up.Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale, from level 1 (no problems) to level 5 (extreme problems or inability), with higher levels indicating worse health status. The EQ visual analogue scale (EQ VAS) ranges from 0 to 100, with higher scores indicating better self-rated health.
Time frame
Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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