Persona Versus NexGen

NCT02269254 | Completed

• 1 other identifier: P13.277
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Comparative Study; Knee Prosthesis; Prosthesis Design; Treatment Outcome; Follow-Up Studies; Arthroplasty, Replacement, Knee/methods

Outcome Measures

Primary Outcomes (1)

• Migration, measured by means of RSA.

  Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).

  2 Years

Secondary Outcomes (4)

• Knee Prosthesis motion by means of Fluoroscopy.

  1 Year

• EQ-5D

  2 Years

• KOOS

  2 Years

• VAS pain

  2 Years

Study Arms (2)

Persona PS

EXPERIMENTAL

Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer

Device: Persona PS Knee Prosthesis by Zimmer

NexGen PS

ACTIVE COMPARATOR

Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

Device: NexGen PS Knee Prosthesis by Zimmer

Interventions

Persona PS Knee Prosthesis by Zimmer DEVICE

Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer

Persona PS

NexGen PS Knee Prosthesis by Zimmer DEVICE

Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

NexGen PS

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Location

MeSH Terms

Conditions

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. PhD MD Head of the Department of Orthopaedics

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 21, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

NL (1)