Zimmer POLAR - Total Knee Arthroplasty (TKA)

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. Identifier: NCT01859130
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

Condition or disease Intervention/treatment Phase
Osteoarthritis RheumatoId Arthritis Traumatic Arthritis Polyarthritis Device: Zimmer Persona Total Knee System Not Applicable

Detailed Description:

The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
Study Start Date : April 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Persona TKA
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Device: Zimmer Persona Total Knee System
Other Names:
  • Primary Knee Replacement,
  • Total Knee Arthroplasty,
  • Total Knee Replacement

Primary Outcome Measures :
  1. Knee Society Scores [ Time Frame: 5 years post op ]

Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 5 years post op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 has participated in a study-related Informed Consent process;
  • 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 Persona fixed bearing knee components 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.

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 identifier (NCT number): NCT01859130

United States, Illinois
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, New Jersey
The Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27701
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Zimmer Biomet

Responsible Party: Zimmer Biomet Identifier: NCT01859130     History of Changes
Other Study ID Numbers: CSU2012-10K
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases