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Trial record 1 of 1 for:    02255383
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Persona Total Knee Arthroplasty Outcomes Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255383
Recruitment Status : Recruiting
First Posted : October 2, 2014
Last Update Posted : October 20, 2021
Sponsor:
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.

Condition or disease Intervention/treatment Phase
Knee Pain Chronic Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Polyarthritis Moderate Varus, Valgus or Flexion Deformities Avascular Necrosis of the Femoral Condyle 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 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, 5, 7, and 10 years.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System
Study Start Date : July 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

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
Primary Total Knee Arthroplasty
Other Names:
  • Total Knee Arthroplasty
  • Total Knee Replacement




Primary Outcome Measures :
  1. Knee Society Score [ Time Frame: 10 years ]
    Knee Society Score


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 10 years ]
    EQ-5D



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.


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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
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: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) 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 provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02255383


Contacts
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Contact: Tim Swanson 5745497606 Tim.Swanson@zimmerbiomet.com
Contact: Kacy Arnold, RN, MBA 574-371-9824 kacy.arnold@zimmerbiomet.com

Locations
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United States, Colorado
Colorado Joint Replacement Active, not recruiting
Denver, Colorado, United States, 80210
Orthopaedic & Spine Center of the Rockies Terminated
Fort Collins, Colorado, United States, 80525
Denver-Vail Orthopedics Active, not recruiting
Parker, Colorado, United States, 80134
United States, Illinois
Rockford Orthopedic Associates Terminated
Rockford, Illinois, United States, 61114
United States, Indiana
Henry County Orthopedics and Sports Medicine Active, not recruiting
New Castle, Indiana, United States, 47362
United States, North Carolina
UNC Department of Orthopaedics Terminated
Chapel Hill, North Carolina, United States, 27599-7055
OrthoCarolina Active, not recruiting
Charlotte, North Carolina, United States, 28207
Raleigh Orthopaedic Clinic Active, not recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Lindner Research Center Active, not recruiting
Cincinnati, Ohio, United States, 45219
SportsMedicine Grant & Orthopaedic Associates Active, not recruiting
Columbus, Ohio, United States, 43215
United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Tennessee Orthopaedic Foundation for Education and Research Active, not recruiting
Knoxville, Tennessee, United States, 37930
United States, Texas
Texas Tech University Health Sciences Center Terminated
Lubbock, Texas, United States, 79430
United States, Virginia
Jordan Young Institute Recruiting
Virginia Beach, Virginia, United States, 23462-1784
Contact: Carolyn Battaglia    757-502-8586    cbattaglia@jordan-younginstitute.com   
Principal Investigator: Louis C Jordan, MD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02255383    
Other Study ID Numbers: CSU2014-02K
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zimmer Biomet:
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Polyarthritis
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes