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Active, not recruiting Observational

Zimmer POLAR Persona - TKA (EMEA Study)

NCT02337244 · tracked via the Priya Life Science UK tracker
Sponsor
Zimmer, GmbH
Phase
Observational
Started
2013-11-18
Last updated
2025-11-25

Condition(s) studied

Severe Knee PainSevere Knee DisabilityOsteoarthritisRheumatoid ArthritisTraumatic ArthritisPolyarthritis

Investigational drug(s) / intervention(s)

Zimmer Persona Total Knee System

Zimmer Persona Total Knee System: No Intervention

Study summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:

1. Implant survivorship based on removal of a study device.
2. Safety based on incidence and frequency of adverse events.
3. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patient 18-75 years of age, inclusive. * Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: * rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; * collagen disorders and/or avascular necrosis of the femoral condyle; * post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; * moderate valgus, varus, or flexion deformities; * the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee. * Patient is willing and able to complete scheduled study procedures and follow-up evaluations. * Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling. Exclusion Criteria: * Patient is currently participating in any other surgical intervention studies or pain management studies. * Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint. * Insufficient bone stock on femoral or tibial surfaces. * Skeletal immaturity. * Neuropathic arthropathy. * Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb. * Stable, painless arthrodesis in a satisfactory functional position. * Severe instability secondary to the absence of collateral ligament integrity. * Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin. * Patient has a known or suspected sensitivity or allergy to one or more of the implant materials. * Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.). * Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

Primary outcome measure(s)

  • Kaplan-Meier Implant Survivorship — 5 years
    Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.

Trial sites (12)

FacilityCityRegionStatus
Orthopädisches Spital Speising Vienna Austria
CHU de Clermont-Ferrand Clermont-Ferrand France
Centre Hospitalier régional Universitaire de Montpellier Montpellier France
HEH Braunschweig Braunschweig Germany
Atos Klinik Heidelberg Heidelberg Germany
Stichting Research Orthopedie & Reinier de Graaf Groep Delft Netherlands
Hospital Parc Tauli Sabadell Spain
Hospital Miguel Servet Zaragoza Spain
University of Leeds Leeds Leeds/UK
Golden Jubilee National Hospital Clydebank United Kingdom
Harrogate and District NHS Harrogate United Kingdom
The Newcastle Upon Tyne Hospitals Newcastle United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02337244 on ClinicalTrials.gov ↗ ← All trials in the UK