Zimmer POLAR Persona - TKA (EMEA Study)

NCT02337244 | Active Not Recruiting

• 1 other identifier: CSE2013-07K
• Study Type: observational
• Target: 777
• Locations: 6 countries
• Sites: 12

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

Conditions

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

Keywords

Osteoarthritis; Rheumatoid arthritis; Traumatic arthritis; Polyarthritis; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier Implant Survivorship

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

  5 years

Secondary Outcomes (4)

• 'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.

  5 years

• 'Forgotten Joint Score' (FJS-12)

  5 years

• Oxford Knee Score (OKS)

  5 years

• EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)

  5 years

Interventions

Zimmer Persona Total Knee System DEVICE

No Intervention

Also known as: Primary Knee Replacement, Total Knee Arthroplasty, Total Knee Replacement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer, GmbH: lead

Study Sites (12)

Orthopädisches Spital Speising

Vienna, 1130, Austria

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier régional Universitaire de Montpellier

Montpellier, 34980, France

Location

HEH Braunschweig

Braunschweig, Germany

Location

Atos Klinik Heidelberg

Heidelberg, Germany

Location

Stichting Research Orthopedie & Reinier de Graaf Groep

Delft, 2612, Netherlands

Location

Hospital Parc Tauli

Sabadell, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

University of Leeds

Leeds, Leeds/UK, LS2 9JT, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

Harrogate and District NHS

Harrogate, HG2 7SX, United Kingdom

Location

The Newcastle Upon Tyne Hospitals

Newcastle, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30832636 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• 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 Tauli, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 13, 2015
• Study Start: November 18, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

GB (4); AU (1); DE (2); FR (2); ES (2); NL (1)