Skip to main content
OpenTrials
Completed

NCT Number: NCT02269254

Persona Versus NexGen

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Connective Tissue Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Persona PS Knee Prosthesis by Zimmer

Device

Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer

NexGen PS Knee Prosthesis by Zimmer

Device

Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. EQ-5D

    Time frame: 2 Years

    General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire

  3. KOOS

    Time frame: 2 Years

    Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire

  4. VAS pain

    Time frame: 2 Years

    Pain score after activity and during rest; (Likert scale 0-10)

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2014
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.