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Active, not recruitingNCT03034811Updated Apr 22, 2026

Persona Partial Knee Clinical Outcomes Study

An interventional study of Persona Partial Knee system in Osteoarthritis, Avascular Necrosis and Traumatic Arthritis, sponsored by Zimmer Biomet. Active, not recruiting at 24 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

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

Phase
Not applicable
Study type
Interventional
Enrollment
757
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

Read the detailed description

The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. 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 partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the 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

  • Osteoarthritis
  • Avascular Necrosis
  • Traumatic Arthritis
  • Conditional Tibial Condyle or Plateau Fractures
  • Conditional Revision of the Articular Surface

Keywords

  • Noninflammatory degenerative joint disease
  • Osteoarthritis
  • Avascular necrosis
  • Traumatic arthritis
  • Partial knee arthroplasty
  • Unicompartmental knee arthroplasty
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient is at least 18 years of age
  • Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.
  • 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/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 the commercially available Persona Partial Knee, implanted in accordance with product labeling

Exclusion criteria

Exclusion Criteria:

  • Patient is currently participating in any other surgical intervention studies or pain management studies
  • Infection, sepsis, and osteomyelitis
  • Rheumatoid arthritis or other forms of inflammatory joint disease
  • Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
  • Full thickness damage to the weight bearing area of the contralateral compartment
  • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  • Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, neuromuscular disease
  • Incomplete or deficient soft tissue surrounding the knee
  • Charcot's disease
  • Fixed varus deformity (not passively correctable) of greater than 15 degrees
  • Fixed flexion deformity (not passively correctable) of greater than 15 degrees
  • Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
04

Study design

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

Study arms

  • Other
    PPK subjects

    Subjects that receive the Persona Partial Knee system

    Device: Persona Partial Knee system

Interventions

  • DevicePersona Partial Knee system

    Fixed bearing partial knee

05

What researchers measure

Primary outcomes

  1. Oxford Knee Score

    A Patient reported functional outcome score for knee arthroplasty

    Time frame: 10 years

Secondary outcomes

  1. EQ-5D

    a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.

    Time frame: 10 years

06

Study locations

24 sites
  • Sah Orthopaedic Associates
    Fremont, California 94538, United States
  • Panorama Orthopedics & Spine Center
    Golden, Colorado 80401, United States
  • Midwest Orthopaedics at Rush
    Chicago, Illinois 60612, United States
  • Henry County Orthopedics and Sports Medicine
    New Castle, Indiana 47362, United States
  • Sports Medicine North
    Beverly, Massachusetts 01960, United States
  • Troy Orthopaedic Associates
    Troy, Michigan 48084, United States
  • New Mexico Orthopaedics
    Albuquerque, New Mexico 87106, United States
  • Midlands Orthopaedics & Neurosurgery
    Columbia, South Carolina 29201, United States
  • Skagit Regional Clinics-Riverbend
    Mount Vernon, Washington 98273, United States
  • Orthopädisches Spital Speising
    Vienna, Austria
  • Cliniques Universitaires Saint-Luc
    Woluwe-Saint-Lambert, Belgium
  • Marseille University-Hospital Centres
    Marseille, France
  • Public Hospital of Versailles
    Versailles, France
  • Hessing Stiftung
    Augsburg, Germany
  • Sana Kliniken Sommerfeld
    Berlin, Germany
  • Waldkrankenhaus Eisenberg
    Eisenberg, Germany
  • Orthopedic Institute IRCCS
    Milan, Italy
  • Fondazione IRCCS Policlinico San Matteo
    Pavia, Italy
  • Hospital Alcorcón
    Madrid, Spain
  • Umea University Hospital
    Umeå, Sweden
  • Hopital d'Yverdon les Bains
    Yverdon-les-Bains, Switzerland
  • Avon Orthopaedic Centre, Southmead Hospital
    Bristol, United Kingdom
  • Royal Derby Hospital
    Derby, United Kingdom
  • Harrogate and District NHS Foundation Trust
    Harrogate, United Kingdom
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
NCT03034811
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Jan 27, 2017
Start date
Feb 8, 2017
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Apr 22, 2026

Study contacts

Hillary Overholser
study director · Zimmer Biomet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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