Persona Versus NexGen

February 7, 2020 updated by: R.G.H.H. Nelissen, Leiden University Medical Center

Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2300RC
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). In case only one of the bones has insufficient markers, the patient will be followed for the other bone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Persona PS
Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer
Device: Persona PS Knee Prosthesis by Zimmer
Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer
Active Comparator: NexGen PS
Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer
Device: NexGen PS Knee Prosthesis by Zimmer
Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migration, measured by means of RSA.
Time Frame: 2 Years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Prosthesis motion by means of Fluoroscopy.
Time Frame: 1 Year
Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis.
1 Year
EQ-5D
Time Frame: 2 Years
General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire
2 Years
KOOS
Time Frame: 2 Years
Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire
2 Years
VAS pain
Time Frame: 2 Years
Pain score after activity and during rest; (Likert scale 0-10)
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Rob GHH Nelissen, Prof. PhD, MD, Dep. Orthopaedics, Leiden University Medical Center
  • Principal Investigator: Edward R Valstar, Prof. PhD. MSc, Dep. Orthopaedics, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13.277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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