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Persona Partial Knee Clinical 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. Identifier: NCT03034811
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : May 31, 2019
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 the commercially available Persona Partial Knee System.

Condition or disease Intervention/treatment Phase
Osteoarthritis Avascular Necrosis Traumatic Arthritis Conditional Tibial Condyle or Plateau Fractures Conditional Revision of the Articular Surface Device: Persona Partial Knee system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persona Partial Knee Clinical Outcomes Study
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
PPK subjects
Subjects that receive the Persona Partial Knee system
Device: Persona Partial Knee system
Fixed bearing partial knee

Primary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 10 years ]
    A Patient reported functional outcome score for knee arthroplasty

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

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.)

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 identifier (NCT number): NCT03034811

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Contact: Tory Sears 574-373-2125
Contact: Kacy Arnold, RN, MBA 574-371-9824

  Hide Study Locations
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United States, California
Sah Orthopaedic Associates Active, not recruiting
Fremont, California, United States, 94538
United States, Colorado
Panorama Orthopedics & Spine Center Active, not recruiting
Golden, Colorado, United States, 80401
United States, Illinois
Midwest Orthopaedics at Rush Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Henry County Orthopedics and Sports Medicine Active, not recruiting
New Castle, Indiana, United States, 47362
United States, Maryland
OrthoBethesda Withdrawn
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Sports Medicine North Active, not recruiting
Beverly, Massachusetts, United States, 01960
United States, Michigan
Troy Orthopaedic Associates Active, not recruiting
Troy, Michigan, United States, 48084
United States, New Mexico
New Mexico Orthopaedics Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, South Carolina
Midlands Orthopaedics & Neurosurgery Active, not recruiting
Columbia, South Carolina, United States, 29201
United States, Washington
Skagit Regional Clinics-Riverbend Active, not recruiting
Mount Vernon, Washington, United States, 98273
Orthopädisches Spital Speising Recruiting
Vienna, Austria
Contact: Martin Dominkus, Prof         
Cliniques Universitaires Saint-Luc Active, not recruiting
Woluwe-Saint-Lambert, Belgium
Marseille University-Hospital Centres Recruiting
Marseille, France
Contact: Jean Noel Argenson, PROF         
Principal Investigator: Jean Noel Argenson, PROF         
Marseille University-Hospital Centres Recruiting
Marseille, France
Contact: Sebastien Parratte, PROF         
Principal Investigator: Sebastien Parratte, PROF         
Public Hospital of Versailles Recruiting
Versailles, France
Contact: Nicolas Pujol, DR         
Principal Investigator: Nicolas Pujol, DR         
Hessing Stiftung Active, not recruiting
Augsburg, Germany
Sana Kliniken Sommerfeld Active, not recruiting
Berlin, Germany
Waldkrankenhaus Eisenberg Recruiting
Eisenberg, Germany
Contact: Georg Matziolis, PROF         
Principal Investigator: Georg Matziolis, PROF         
Orthopedic Institute IRCCS Active, not recruiting
Milan, Italy
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy
Contact: Francesco Benazzo, DR         
Principal Investigator: Francesco Benazzo, DR         
Hospital Alcorcón Recruiting
Madrid, Spain
Contact: Javier Martinez, DR         
Principal Investigator: Javier Martinez, DR         
Umea University Hospital Active, not recruiting
Umea, Sweden
Hopital d'Yverdon les Bains Recruiting
Yverdon les Bains, Switzerland
Contact: Alexandre Lunebourg, DR         
Principal Investigator: Alexandre Lunebourg, DR         
United Kingdom
Avon Orthopaedic Centre, Southmead Hospital Recruiting
Bristol, United Kingdom
Contact: Andrew Porteous, MD         
Principal Investigator: Andrew Porteous, MD         
Royal Derby Hospital Recruiting
Derby, United Kingdom
Contact: Rob Straw, DR         
Principal Investigator: Rob Straw, DR         
Harrogate and District NHS Foundation Trust Active, not recruiting
Harrogate, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
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Study Director: Kacy Arnold, RN, MBA Zimmer Biomet

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Responsible Party: Zimmer Biomet Identifier: NCT03034811     History of Changes
Other Study ID Numbers: K.CR.I.G.16.16
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zimmer Biomet:
Noninflammatory degenerative joint disease
Avascular necrosis
Traumatic arthritis
Partial knee arthroplasty
Unicompartmental knee arthroplasty

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Bone Diseases