Last updated on August 2020

Zimmer POLAR Persona - TKA (EMEA Study)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rheumatoid Arthritis | Osteoarthritis | Severe Knee Pain | Traumatic Arthritis | Arthritis and Arthritic Pain | Rheumatoid Arthritis (Pediatric) | Severe Knee Disability | Arthritis | Arthritis and Arthritic Pain (Pediatric)
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patient 18-75 years of age, inclusive.
  • Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
  • rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
  • collagen disorders and/or avascular necrosis of the femoral condyle;
  • post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
  • moderate valgus, varus, or flexion deformities;
  • the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
  • Patient is willing and able to complete scheduled study procedures and follow-up evaluations.
  • Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling.

Exclusion Criteria:

  • Patient is currently participating in any other surgical intervention studies or pain management studies.
  • Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
  • Insufficient bone stock on femoral or tibial surfaces.
  • Skeletal immaturity.
  • Neuropathic arthropathy.
  • Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
  • Stable, painless arthrodesis in a satisfactory functional position.
  • Severe instability secondary to the absence of collateral ligament integrity.
  • Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
  • Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
  • Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
  • Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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