Persona Versus NexGen

NCT ID: NCT02269254

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-06-30

Brief Summary

The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet.

The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures.

This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis.

Different sample sizes are used for the different parts of this study:

• 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA
• 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo

The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period.

Main study parameters/endpoints are:

• Migration, measured by means of RSA.
• Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts.
• In vivo kinematics by means of fluoroscopy.
• Patient Reported Outcome Measures by means of questionaires.

Conditions

Osteoarthritis Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Persona PS

Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer

Group Type: EXPERIMENTAL

Persona PS Knee Prosthesis by Zimmer

Intervention Type: DEVICE

Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer

NexGen PS

Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

Group Type: ACTIVE_COMPARATOR

NexGen PS Knee Prosthesis by Zimmer

Intervention Type: DEVICE

Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

Interventions

Persona PS Knee Prosthesis by Zimmer

Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer

Intervention Type: DEVICE

NexGen PS Knee Prosthesis by Zimmer

Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty
• Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Stratification is performed per diagnosis group (OA/RA).

Exclusion Criteria

• The patient is unable or unwilling to sign the Informed Consent specific to this study
• Insufficient Dutch or English language skills
• Patients indicated for revision arthroplasty
• Patient is (or might be) pregnant

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

R.G.H.H. Nelissen

Prof. PhD MD Head of the Department of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rob GHH Nelissen, Prof. PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. Orthopaedics, Leiden University Medical Center

Edward R Valstar, Prof. PhD. MSc

Role: PRINCIPAL_INVESTIGATOR

Dep. Orthopaedics, Leiden University Medical Center

Locations

Leiden University Medical Center

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

P13.277

Identifier Type: -

Identifier Source: org_study_id