Persona Partial Knee Clinical Outcomes Study

NCT ID: NCT03034811

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 643 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2029-07-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PPK subjects

Subjects that receive the Persona Partial Knee system

Group Type: OTHER

Persona Partial Knee system

Intervention Type: DEVICE

Fixed bearing partial knee

Interventions

Persona Partial Knee system

Fixed bearing partial knee

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Sah Orthopaedic Associates

Fremont, California, United States

Panorama Orthopedics & Spine Center

Golden, Colorado, United States

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Henry County Orthopedics and Sports Medicine

New Castle, Indiana, United States

Sports Medicine North

Beverly, Massachusetts, United States

Troy Orthopaedic Associates

Troy, Michigan, United States

New Mexico Orthopaedics

Albuquerque, New Mexico, United States

Midlands Orthopaedics & Neurosurgery

Columbia, South Carolina, United States

Skagit Regional Clinics-Riverbend

Mount Vernon, Washington, 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

Countries

United States; Austria; Belgium; France; Germany; Italy; Spain; Sweden; Switzerland; United Kingdom

Other Identifiers

K.CR.I.G.16.16

Identifier Type: -

Identifier Source: org_study_id