Persona Partial Knee Clinical Outcomes Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Conditional Tibial Condyle or Plateau Fractures; Conditional Revision of the Articular Surface
• Intervention / Treatment: Device: Persona Partial Knee system

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.

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Orthopädisches Spital Speising
• Belgium
  • Woluwe-Saint-Lambert, Belgium
    • Cliniques Universitaires Saint-Luc
• France
  • Marseille, France
    • Marseille University-Hospital Centres
  • Versailles, France
    • Public Hospital of Versailles
• Germany
  • Augsburg, Germany
    • Hessing Stiftung
  • Berlin, Germany
    • Sana Kliniken Sommerfeld
  • Eisenberg, Germany
    • Waldkrankenhaus Eisenberg
• Italy
  • Milan, Italy
    • Orthopedic Institute IRCCS
  • Pavia, Italy
    • Fondazione IRCCS Policlinico San matteo
• Spain
  • Madrid, Spain
    • Hospital Alcorcón
• Sweden
  • Umeå, Sweden
    • Umea University Hospital
• Switzerland
  • Yverdon-les-Bains, Switzerland
    • Hopital d'Yverdon les Bains
• United Kingdom
  • Bristol, United Kingdom
    • Avon Orthopaedic Centre, Southmead Hospital
  • Derby, United Kingdom
    • Royal Derby Hospital
  • Harrogate, United Kingdom
    • Harrogate and District NHS Foundation Trust
• United States
  • California
    • Fremont, California, United States, 94538
      • Sah Orthopaedic Associates
  • Colorado
    • Golden, Colorado, United States, 80401
      • Panorama Orthopedics & Spine Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopaedics at Rush
  • Indiana
    • New Castle, Indiana, United States, 47362
      • Henry County Orthopedics and Sports Medicine
  • Massachusetts
    • Beverly, Massachusetts, United States, 01960
      • Sports Medicine North
  • Michigan
    • Troy, Michigan, United States, 48084
      • Troy Orthopaedic Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Orthopaedics
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Midlands Orthopaedics & Neurosurgery
  • Washington
    • Mount Vernon, Washington, United States, 98273
      • Skagit Regional Clinics-Riverbend

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PPK subjects; Subjects that receive the Persona Partial Knee system	Device: Persona Partial Knee system; Fixed bearing partial knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score	A Patient reported functional outcome score for knee arthroplasty	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimated): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Avascular necrosis; Unicompartmental knee arthroplasty; Traumatic arthritis; Partial knee arthroplasty; Noninflammatory degenerative joint disease
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Necrosis; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Osteonecrosis
• Other Study ID Numbers: K.CR.I.G.16.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes