Persona Versus NexGen
Condition: Osteoarthritis Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases
MeSH terms: Osteoarthritis; Rheumatic Diseases; Joint Diseases; Musculoskeletal Diseases; Collagen Diseases
Study type: Interventional

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.
    


Intervention name(s): Persona PS Knee Prosthesis by Zimmer; NexGen PS Knee Prosthesis by Zimmer
Intervention type(s): Device; Device
Intervention description(s): Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer; Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Comparative Study; Knee Prosthesis; Prosthesis Design; Treatment Outcome; Follow-Up Studies; Arthroplasty, Replacement, Knee/methods