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Active, not recruitingNCT02255383Updated Mar 10, 2026

Persona Total Knee Arthroplasty Outcomes Study

An interventional study of Zimmer Persona Total Knee System in Knee Pain Chronic, Osteoarthritis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Active, not recruiting at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
737
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Pain Chronic
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Polyarthritis
  • Moderate Varus, Valgus or Flexion Deformities
  • Avascular Necrosis of the Femoral Condyle

Keywords

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Polyarthritis
  • Total Knee Arthroplasty
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
737 participants (actual)

Study arms

  • Other
    PERSONA TKA

    Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

    Device: Zimmer Persona Total Knee System

Interventions

  • DeviceZimmer Persona Total Knee System

    Primary Total Knee Arthroplasty

    Also known as: Total Knee Arthroplasty, Total Knee Replacement

05

What researchers measure

Primary outcomes

  1. Knee Society Score

    Knee Society Score

    Time frame: 10 years

Secondary outcomes

  1. EQ-5D

    EQ-5D

    Time frame: 10 years

06

Study locations

14 sites
  • Colorado Joint Replacement
    Denver, Colorado 80210, United States
  • Orthopaedic & Spine Center of the Rockies
    Fort Collins, Colorado 80525, United States
  • Denver-Vail Orthopedics
    Parker, Colorado 80134, United States
  • Rockford Orthopedic Associates
    Rockford, Illinois 61114, United States
  • Henry County Orthopedics and Sports Medicine
    New Castle, Indiana 47362, United States
  • UNC Department of Orthopaedics
    Chapel Hill, North Carolina 27599-7055, United States
  • OrthoCarolina
    Charlotte, North Carolina 28207, United States
  • Raleigh Orthopaedic Clinic
    Raleigh, North Carolina 27612, United States
  • Lindner Research Center
    Cincinnati, Ohio 45219, United States
  • SportsMedicine Grant & Orthopaedic Associates
    Columbus, Ohio 43215, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Tennessee Orthopaedic Foundation for Education and Research
    Knoxville, Tennessee 37930, United States
  • Texas Tech University Health Sciences Center
    Lubbock, Texas 79430, United States
  • Jordan Young Institute
    Virginia Beach, Virginia 23462-1784, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02255383
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Oct 2, 2014
Start date
Jul 2014
Primary completion
Dec 2025
Completion
Dec 2027 (estimated)
Last update
Mar 10, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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