Persona Ti-Nidium Post-Market Clinical Follow-up

Running, not enrolling · Not applicable

Conditions studied: Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Varus Deformity, Valgus Deformity, Flexion Deformity of the Knee, Avascular Necrosis, Patellofemoral Osteoarthritis

In brief

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

Key facts

Study ID

NCT04817969

Run by

Zimmer Biomet

People needed

240

Starts

2021-06-01

Expected to finish

2034-05-01

Last updated by the study team

2025-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• A stable, painless arthrodesis in a satisfactory functional position
• Severe instability secondary to the absence of collateral ligament integrity
• Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency

Where it is running

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

Full record on ClinicalTrials.gov

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