Zimmer POLAR Persona - TKA (EMEA Study)

Sponsor

Zimmer, GmbH (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02337244

Collaborator

(none)

777

Enrollment

Locations

153.4

Anticipated Duration (Months)

64.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Severe Knee Pain Severe Knee Disability Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Polyarthritis	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 Design

Study Type:

Observational

Actual Enrollment :

777 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 18, 2013

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Outcome Measures

Primary Outcome Measures

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

'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.
'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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopädisches Spital Speising	Wien		Austria	1130
2	CHU de Clermont-Ferrand	Clermont-Ferrand		France	63003
3	Centre Hospitalier régional Universitaire de Montpellier	Montpellier		France	34980
4	HEH Braunschweig	Braunschweig		Germany
5	Atos Klinik Heidelberg	Heidelberg		Germany
6	Stichting Research Orthopedie & Reinier de Graaf Groep	Delft		Netherlands	2612
7	Hospital Parc Tauli	Sabadell		Spain
8	Hospital Miguel Servet	Zaragoza		Spain
9	University of Leeds	Leeds	Leeds/UK	United Kingdom	LS2 9JT
10	Golden Jubilee National Hospital	Clydebank		United Kingdom
11	Harrogate and District NHS	Harrogate		United Kingdom	HG2 7SX
12	The Newcastle Upon Tyne Hospitals	Newcastle		United Kingdom

Sponsors and Collaborators

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 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