Who is eligible for clinical trial NCT04817969?

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

Does clinical trial NCT04817969 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 2026-08-13

Persona Ti-Nidium Post-Market Clinical Follow-up (NCT04817969)

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

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

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (16 items).

Location: Denver Hip & Knee, Inc. — Parker, Colorado

📋 "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 of legal age and skeletally mature
Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface
Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling Study Device Inclusion Criteria: The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patient is unwilling to sign the Informed Consent
Patient is currently participating in any other surgical intervention or pain management study
Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation Study Device Exclusion Criteria
Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb

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

📍 All Participating Trial Locations (7 Sites)

Denver Hip & Knee, Inc. — Parker, Colorado
MedStar Health Research Institute — Hyattsville, Maryland
Mississippi Sports Medicine and Orthopaedic Center — Jackson, Mississippi
New Mexico Orthopaedic Associates — Albuquerque, New Mexico
Duke University — Durham, North Carolina
Rothman Orthopaedic Institute — Philadelphia, Pennsylvania
Monument Health Rapid City Hospital, Inc. — Rapid City, South Dakota

💰 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 ↗