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Zimmer POLAR - Total Knee Arthroplasty (TKA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01859130
First Posted: May 21, 2013
Last Update Posted: November 23, 2016
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.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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 Intervention
Osteoarthritis RheumatoId Arthritis Traumatic Arthritis Polyarthritis Device: Zimmer Persona Total Knee System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

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

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

Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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): NCT01859130


Locations
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
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01859130     History of Changes
Other Study ID Numbers: CSU2012-10K
First Submitted: May 16, 2013
First Posted: May 21, 2013
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
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases