Clincosm LogoSign in Get a demo

Persona Total Knee Arthroplasty Outcomes Study

Sponsor
Zimmer Biomet (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02255383
Collaborator
(none)
1,000
Enrollment
14
Locations
1
Arm
161
Duration (Months)
71.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Zimmer Persona Total Knee System
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Knee Society Score [10 years]

      Knee Society Score

    Secondary Outcome Measures

    1. EQ-5D [10 years]

      EQ-5D

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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: 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colorado Joint Replacement Denver Colorado United States 80210
    2 Orthopaedic & Spine Center of the Rockies Fort Collins Colorado United States 80525
    3 Denver-Vail Orthopedics Parker Colorado United States 80134
    4 Rockford Orthopedic Associates Rockford Illinois United States 61114
    5 Henry County Orthopedics and Sports Medicine New Castle Indiana United States 47362
    6 UNC Department of Orthopaedics Chapel Hill North Carolina United States 27599-7055
    7 OrthoCarolina Charlotte North Carolina United States 28207
    8 Raleigh Orthopaedic Clinic Raleigh North Carolina United States 27612
    9 Lindner Research Center Cincinnati Ohio United States 45219
    10 SportsMedicine Grant & Orthopaedic Associates Columbus Ohio United States 43215
    11 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    12 Tennessee Orthopaedic Foundation for Education and Research Knoxville Tennessee United States 37930
    13 Texas Tech University Health Sciences Center Lubbock Texas United States 79430
    14 Jordan Young Institute Virginia Beach Virginia United States 23462-1784

    Sponsors and Collaborators

    • Zimmer Biomet

    Investigators

    • Study Director: Kacy Arnold, RN, MBA, Zimmer Biomet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT02255383
    Other Study ID Numbers:
    • CSU2014-02K
    First Posted:
    Oct 2, 2014
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Zimmer Biomet
    Osteoarthritis
    Rheumatoid Arthritis
    Traumatic Arthritis
    Polyarthritis
    Total Knee Arthroplasty
    Additional relevant MeSH terms:
    Arthritis
    Osteoarthritis
    Arthritis, Rheumatoid
    Necrosis

    Study Results

    No Results Posted as of Oct 20, 2021