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Clinical Trials in the USA / NCT03034811
Active, not recruiting Not applicable

Persona Partial Knee Clinical Outcomes Study

NCT03034811 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2017-02-08
Last updated
2026-04-22

Condition(s) studied

OsteoarthritisAvascular NecrosisTraumatic ArthritisConditional Tibial Condyle or Plateau FracturesConditional Revision of the Articular Surface

Investigational drug(s) / intervention(s)

Persona Partial Knee system

Persona Partial Knee system: Fixed bearing partial knee

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.)

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Sah Orthopaedic Associates Fremont California
Panorama Orthopedics & Spine Center Golden Colorado
Midwest Orthopaedics at Rush Chicago Illinois
Henry County Orthopedics and Sports Medicine New Castle Indiana
Sports Medicine North Beverly Massachusetts
Troy Orthopaedic Associates Troy Michigan
New Mexico Orthopaedics Albuquerque New Mexico
Midlands Orthopaedics & Neurosurgery Columbia South Carolina
Skagit Regional Clinics-Riverbend Mount Vernon Washington
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

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03034811 on ClinicalTrials.gov ↗ ← All trials in the USA