Who is eligible for clinical trial NCT03034811?

Participants must meet protocol criteria for Osteoarthritis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT03034811 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-17

Persona Partial Knee Clinical Outcomes Study (NCT03034811)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Zimmer Biomet

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (18 items).

Location: Sah Orthopaedic Associates — Fremont, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (24 Sites)

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,
Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert,
Marseille University-Hospital Centres — Marseille,
Public Hospital of Versailles — Versailles,
Hessing Stiftung — Augsburg,
Sana Kliniken Sommerfeld — Berlin,
Waldkrankenhaus Eisenberg — Eisenberg,
Orthopedic Institute IRCCS — Milan,
Fondazione IRCCS Policlinico San Matteo — Pavia,
Hospital Alcorcón — Madrid,
Umea University Hospital — Umeå,
Hopital d'Yverdon les Bains — Yverdon-les-Bains,
Avon Orthopaedic Centre, Southmead Hospital — Bristol,
Royal Derby Hospital — Derby,
Harrogate and District NHS Foundation Trust — Harrogate,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗