Zimmer POLAR Persona - TKA (EMEA Study)

NCT ID: NCT02337244

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 777 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-18
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

Severe Knee Pain; Severe Knee Disability; Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Zimmer Persona Total Knee System

No Intervention

Intervention Type: DEVICE

Other Intervention Names

Primary Knee Replacement; Total Knee Arthroplasty; Total Knee Replacement

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer, GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Dominkus, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopädisches Spital Speising, Wien, Austria

Hendrik Verburg, MD

Role: PRINCIPAL_INVESTIGATOR

Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands

Nicholas London, MD

Role: PRINCIPAL_INVESTIGATOR

Harrogate and District NHS, Harrogate, England

Stéphane Boisgard, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand, Clermont-Ferrand, France

François Canovas, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospital Lapeyronie, Montpellier

Pere Torner, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Parc Tauli, Sabadell

Jon Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Golden Jubilee National Hospital, Clydebank

David Deehan, Prof

Role: PRINCIPAL_INVESTIGATOR

Freeman Hospital, Newcastle

Karl Dieter Heller, Prof

Role: PRINCIPAL_INVESTIGATOR

HEH Braunschweig

Fritz Thorey, Prof

Role: PRINCIPAL_INVESTIGATOR

Atos Klinik Heidelberg

Fernando Martinez Delgado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet Zaragoza

Hermant Pandit, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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, United Kingdom

Golden Jubilee National Hospital

Clydebank, , United Kingdom

Harrogate and District NHS

Harrogate, , United Kingdom

The Newcastle Upon Tyne Hospitals

Newcastle, , United Kingdom

Countries

Austria; France; Germany; Netherlands; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30832636 (View on PubMed)

Other Identifiers

CSE2013-07K

Identifier Type: -

Identifier Source: org_study_id