Persona Partial Knee Clinical Outcomes Study
Running, not enrolling · Not applicable
Conditions studied: Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Conditional Tibial Condyle or Plateau Fractures, Conditional Revision of the Articular Surface
In brief
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
Key facts
- Study ID
- NCT03034811
- Run by
- Zimmer Biomet
- People needed
- 757
- Starts
- 2017-02-08
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.)
Where it is running
- 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
Full record on ClinicalTrials.gov
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