Zimmer POLAR Persona - TKA (EMEA Study)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02337244
• Other study ID #: CSE2013-07K
• Status: Active, not recruiting
• Start date: November 18, 2013
• Est. completion date: December 2027

Study information

• Verified date: February 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 777
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Polyarthritis
• Rheumatoid Arthritis
• Severe Knee Disability
• Severe Knee Pain
• Traumatic Arthritis

Intervention

Device:
• Zimmer Persona Total Knee System
No Intervention

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, GmbH

Countries where clinical trial is conducted

Austria,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier Implant Survivorship	Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.	5 years
Secondary	'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
Secondary	'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
Secondary	Oxford Knee Score (OKS)	The score related to the OKS patient-reported questionaire calculated at different time points until 5 years.	5 years
Secondary	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