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Persona Versus NexGen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02269254
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
R.G.H.H. Nelissen, Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Device: Persona PS Knee Prosthesis by Zimmer Device: NexGen PS Knee Prosthesis by Zimmer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254


Locations
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Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300RC
Sponsors and Collaborators
Leiden University Medical Center
Zimmer Biomet
Investigators
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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
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Responsible Party: R.G.H.H. Nelissen, Prof. PhD MD Head of the Department of Orthopaedics, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02269254    
Other Study ID Numbers: P13.277
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Keywords provided by R.G.H.H. Nelissen, Leiden University Medical Center:
Comparative Study
Knee Prosthesis
Prosthesis Design
Treatment Outcome
Follow-Up Studies
Arthroplasty, Replacement, Knee/methods
Additional relevant MeSH terms:
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Osteoarthritis
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Collagen Diseases
Arthritis
Connective Tissue Diseases