Last updated on August 2017

Persona Partial Knee Clinical Outcomes Study


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT03034811

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Alexander P Sah, MD

Dearborn-Sah Institute for Joint Restoration
Fremont, CA United States
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Jared RH Foran, MD

Panorama Orthopedics & Spine Center
Golden, CO United States
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Denis Nam, MD

Midwest Orthopaedics at Rush
Chicago, IL United States
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Lindsey R Rolston, MD

Henry County Orthopedics and Sports Medicine
New Castle, IN United States
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Christopher J Cannova, MD

OrthoBethesda
Bethesda, MD United States
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Ira K Evans, MD

Sports Medicine North
Beverly, MA United States
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Donald M Knapke, MD

Troy Orthopaedic Associates
Troy, MI United States
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Samuel K Tabet, MD

New Mexico Orthopaedics
Albuquerque, NM United States
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James A O'Leary, MD

Midlands Orthopaedics & Neurosurgery
Columbia, SC United States
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Richard Williamson, MD

Skagit Regional Clinics-Riverbend
Mount Vernon, WA United States
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Emmanuel Thienpont, PROF

Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
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Sebastien Parratte, PROF

Marseille University-Hospital Centres
Marseille, France
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Patrick Le Couteur, DR

Polyclinique de l'Atlantique
Nantes, France
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Nicolas Pujol, DR

Public Hospital of Versailles
Versailles, France
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Jan Tomas, Dr

Hessing Stiftung
Augsburg, Germany
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Alexander Halder, PROF

Sana Kliniken Sommerfeld
Berlin, Germany
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Georg Matziolis, PROF

Waldkrankenhaus Eisenberg
Eisenberg, Germany
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Stephan Kirschner, DR

St.Vincentius Kliniken
Karlsruhe, Germany
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Sergio Romagnoli, PROF

Orthopedic Institute IRCCS
Milan, Italy
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Francesco Benazzo, DR

Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
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Javier Martinez, DR

Hospital Alcorc n
Madrid, Spain
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Kjell Nilsson, PROF

Umea University Hospital
Umea, Sweden
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Thomas Wiesner, DR

Berit Paracelsus Klinik
Speicher, Switzerland
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Alexandre Lunebourg, DR

Hopital d'Yverdon les Bains
Yverdon les Bains, Switzerland
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Andrew Porteous, MD

Avon Orthopaedic Centre, Southmead Hospital
Bristol, United Kingdom
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Rob Straw, DR

Royal Derby Hospital
Derby, United Kingdom
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Nick London, PROF

Harrogate and District NHS Foundation Trust
Harrogate, United Kingdom
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Richard Parkinson, DR

Clatterbridge Hospital
Wirral, United Kingdom
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