Persona Partial Knee Clinical Outcomes Study

Not Applicable

Active, not recruiting

• Conditions: Conditional Revision of the Articular Surface; Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Conditional Tibial Condyle or Plateau Fractures
• Interventions: Device: Persona Partial Knee system

• Registration Number: NCT03034811
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-02-08
• Status Verified: 2024-12
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2027-09
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 643

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPK subjects	Persona Partial Knee system	Subjects that receive the Persona Partial Knee system

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score	10 years	A Patient reported functional outcome score for knee arthroplasty

Secondary Outcome Measures

Name	Time	Method
EQ-5D	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.

Trial Locations

Locations (24)

Sah Orthopaedic Associates; 🇺🇸 Fremont, California, United States

Orthopädisches Spital Speising; 🇦🇹 Vienna, Austria

Waldkrankenhaus Eisenberg; 🇩🇪 Eisenberg, Germany

Midlands Orthopaedics & Neurosurgery; 🇺🇸 Columbia, South Carolina, United States

Panorama Orthopedics & Spine Center; 🇺🇸 Golden, Colorado, United States

Henry County Orthopedics and Sports Medicine; 🇺🇸 New Castle, Indiana, United States

Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Sports Medicine North; 🇺🇸 Beverly, Massachusetts, United States

New Mexico Orthopaedics; 🇺🇸 Albuquerque, New Mexico, United States

Troy Orthopaedic Associates; 🇺🇸 Troy, Michigan, United States

Cliniques Universitaires Saint-Luc; 🇧🇪 Woluwe-Saint-Lambert, Belgium

Skagit Regional Clinics-Riverbend; 🇺🇸 Mount Vernon, Washington, United States

Marseille University-Hospital Centres; 🇫🇷 Marseille, France

Public Hospital of Versailles; 🇫🇷 Versailles, France

Hessing Stiftung; 🇩🇪 Augsburg, Germany

Sana Kliniken Sommerfeld; 🇩🇪 Berlin, Germany

Orthopedic Institute IRCCS; 🇮🇹 Milan, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Umea University Hospital; 🇸🇪 Umea, Sweden

Hospital Alcorcón; 🇪🇸 Madrid, Spain

Avon Orthopaedic Centre, Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Hopital d'Yverdon les Bains; 🇨🇭 Yverdon les Bains, Switzerland

Harrogate and District NHS Foundation Trust; 🇬🇧 Harrogate, United Kingdom

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom