Zimmer POLAR Persona - TKA (EMEA Study)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Severe Knee Pain; Severe Knee Disability
• Intervention / Treatment: Device: Zimmer Persona Total Knee System

Detailed Description

This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.

• Study Type: Observational
• Enrollment (Actual): 777

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1130
    • Orthopädisches Spital Speising
• France
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont-Ferrand
  • Montpellier, France, 34980
    • Centre Hospitalier Régional Universitaire de Montpellier
• Germany
  • Braunschweig, Germany
    • HEH Braunschweig
  • Heidelberg, Germany
    • Atos Klinik Heidelberg
• Netherlands
  • Delft, Netherlands, 2612
    • Stichting Research Orthopedie & Reinier de Graaf Groep
• Spain
  • Sabadell, Spain
    • Hospital Parc Tauli
  • Zaragoza, Spain
    • Hospital Miguel Servet
• United Kingdom
  • Clydebank, United Kingdom
    • Golden Jubilee National Hospital
  • Harrogate, United Kingdom, HG2 7SX
    • Harrogate and District NHS
  • Newcastle, United Kingdom
    • The Newcastle Upon Tyne Hospitals
  • Leeds/UK
    • Leeds, Leeds/UK, United Kingdom, LS2 9JT
      • University of Leeds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier Implant Survivorship	Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.	The scores related to the five KOOS subscales calculated at different time points until 5 years.	5 years
'Forgotten Joint Score' (FJS-12)	The score related to the FJS-12 patient-reported questionaire calculated at different time points until 5 years.	5 years
Oxford Knee Score (OKS)	The score related to the OKS patient-reported questionaire calculated at different time points until 5 years.	5 years
EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)	The scores related to the EQ-5D-3L questionnaire and the EQ-VAS calculated at different time points until 5 years.	5 years

Collaborators and Investigators

• Sponsor: Zimmer, GmbH
• Investigators: Principal Investigator: Martin Dominkus, MD, Orthopädisches Spital Speising, Wien, Austria; Principal Investigator: Hendrik Verburg, MD, Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands; Principal Investigator: Nicholas London, MD, Harrogate and District NHS, Harrogate, England; Principal Investigator: Stéphane Boisgard, MD, CHU de Clermont-Ferrand, Clermont-Ferrand, France; Principal Investigator: François Canovas, Prof, Hospital Lapeyronie, Montpellier; Principal Investigator: Pere Torner, MD, Hospital Parc Taulí, Sabadell; Principal Investigator: Jon Clarke, MD, Golden Jubilee National Hospital, Clydebank; Principal Investigator: David Deehan, Prof, Freeman Hospital, Newcastle; Principal Investigator: Karl Dieter Heller, Prof, HEH Braunschweig; Principal Investigator: Fritz Thorey, Prof, Atos Klinik Heidelberg; Principal Investigator: Fernando Martinez Delgado, MD, Hospital Miguel Servet Zaragoza; Principal Investigator: Hermant Pandit, Prof, University of Leeds

Publications and helpful links

General Publications

• Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2013
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Total knee arthroplasty; Rheumatoid arthritis; Traumatic arthritis; Polyarthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis
• Other Study ID Numbers: CSE2013-07K