Persona Ti-Nidium Post-Market Clinical Follow-up

Last updated: February 6, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Osteoarthritis

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

Zimmer Biomet Persona Ti-Nidium Total Knee System

Clinical Study ID

NCT04817969
CMG2020-05K
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is of legal age and skeletally mature

  2. Patient is willing and able to provide written Informed Consent by signing anddating the IRB-approved Informed Consent document

  3. Patient is willing and able to complete scheduled follow-up evaluations as definedin the study protocol

  4. Patient qualifies for total knee arthroplasty based upon physical exam and medicalhistory, and meets the approved indications for use of the Persona Ti-Nidium KneeSystem and Vivacit-E polyethylene articulating surface

  5. Independent of study participation, patient is a candidate for the commerciallyavailable 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:

  1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

  2. Collagen disorders, and/or avascular necrosis of the femoral condyle.

  3. Post-traumatic loss of joint configuration, particularly when there ispatellofemoral erosion, dysfunction or prior patellectomy.

  4. Moderate valgus, varus, or flexion deformities.

Exclusion

Exclusion Criteria:

  1. Patient is unwilling to sign the Informed Consent

  2. Patient is currently participating in any other surgical intervention or painmanagement study

  3. Patient is pregnant or considered a member of a protected (vulnerable) populationwhose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)

  4. Patient has a mental or neurologic condition who is unwilling or incapable offollowing postoperative care instructions

  5. Patient has a condition which would, in the judgement of the Investigator, place thepatient at undue risk or interfere with the conduct of the study

  6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannotunderstand the requirements of study participation

Study Device Exclusion Criteria

  1. Previous history of infection in the affected joint and/or other local/systematicinfection that may affect the prosthetic joint

  2. Insufficient bone stock on femoral or tibial surfaces

  3. Skeletal immaturity

  4. Neuropathic arthropathy

  5. Osteoporosis or any loss of musculature or neuromuscular disease that compromisesthe affected limb

  6. A stable, painless arthrodesis in a satisfactory functional position

  7. Severe instability secondary to the absence of collateral ligament integrity

  8. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history ofrecurrent breakdown of the skin

  9. The kinematic alignment surgical technique is contraindicated for patients withgreater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Zimmer Biomet Persona Ti-Nidium Total Knee System
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
May 31, 2034

Study Description

The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium Total Knee System. The study will require each site to obtain institutional review board (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 total knee arthroplasty. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively.

The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Specific assessments include:

  1. Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium total knee system and instrumentation in primary and revision TKA.

  2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).

Connect with a study center

  • Denver Hip & Knee, Inc.

    Parker, Colorado 80134
    United States

    Site Not Available

  • MedStar Health Research Institute

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Mississippi Sports Medicine and Orthopaedic Center

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • New Mexico Orthopaedic Associates

    Albuquerque, New Mexico 87110
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27708
    United States

    Site Not Available

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota 57701
    United States

    Site Not Available

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