Zimmer POLAR Persona - TKA (EMEA Study)

Active, not recruiting

• Conditions: Severe Knee Disability; Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Severe Knee Pain

• Registration Number: NCT02337244
• Lead Sponsor: Zimmer, GmbH

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.

Study Timeline

• Study Start: 2013-11-18
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 777

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (12)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier régional Universitaire de Montpellier; 🇫🇷 Montpellier, France

Stichting Research Orthopedie & Reinier de Graaf Groep; 🇳🇱 Delft, Netherlands

Atos Klinik Heidelberg; 🇩🇪 Heidelberg, Germany

HEH Braunschweig; 🇩🇪 Braunschweig, Germany

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

University of Leeds; 🇬🇧 Leeds, Leeds/UK, United Kingdom

Hospital Parc Tauli; 🇪🇸 Sabadell, Spain

Golden Jubilee National Hospital; 🇬🇧 Clydebank, United Kingdom

Harrogate and District NHS; 🇬🇧 Harrogate, United Kingdom

The Newcastle Upon Tyne Hospitals; 🇬🇧 Newcastle, United Kingdom

Orthopädisches Spital Speising; 🇦🇹 Wien, Austria