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

March 6, 2024 updated by: Zimmer Biomet

Persona® Ti-Nidium® Personalized Total Knee System A Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data Using the Persona Ti-Nidium Total Knee System and Instrumentation

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Parker, Colorado, United States, 80134
        • Denver Hip & Knee, Inc.
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Mississippi Sports Medicine and Orthopaedic Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • New Mexico Orthopaedic Associates
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Rapid City Hospital, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is of legal age and skeletally mature
  2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
  3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
  4. 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
  5. 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:

  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 is patellofemoral erosion, dysfunction or prior patellectomy.
  4. Moderate valgus, varus, or flexion deformities.

Exclusion Criteria:

  1. Patient is unwilling to sign the Informed Consent
  2. Patient is currently participating in any other surgical intervention or pain management study
  3. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
  4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
  5. 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
  6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation

Study Device Exclusion Criteria

  1. Previous history of infection in the affected joint and/or other local/systematic infection 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 compromises the 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 of recurrent breakdown of the skin
  9. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Persona Ti-Nidium
Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System
Device: Zimmer Biomet Persona Ti-Nidium Total Knee System
Primary Knee Total Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score (OKS)
Time Frame: 10 years
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score (KSS) Expectations (pre and post op)
Time Frame: 10 years
This is a 3 question form regarding a patient's expectations of the total knee replacement. The pre-op form assesses the patient's expectations of the knee replacement, and the post-op form addresses how the replacement is meeting said expectations. The score ranges from 3-15, with higher scores indicating a better outcome.
10 years
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
Time Frame: 10 years
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Hillary Overholser, Zimmer Biomet Assoc Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

May 1, 2034

Study Completion (Estimated)

May 1, 2034

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMG2020-05K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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