Persona Ti-Nidium Post-Market Clinical Follow-up

NCT04817969 | Active Not Recruiting FDA Device

• 1 other identifier: CMG2020-05K
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Knee Pain Chronic; Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Varus Deformity; Valgus Deformity; Flexion Deformity of the Knee; Avascular Necrosis; Patellofemoral Osteoarthritis

Keywords

Osteoarthritis; Rheumatoid Arthritis; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score (OKS)

  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 Outcomes (2)

• Knee Society Score (KSS) Expectations (pre and post op)

  10 years

• EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure

  10 years

Study Arms (1)

Persona Ti-Nidium

OTHER

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

Interventions

Zimmer Biomet Persona Ti-Nidium Total Knee System DEVICE

Primary Knee Total Arthroplasty

Persona Ti-Nidium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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 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
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (7)

Denver Hip & Knee, Inc.

Parker, Colorado, 80134, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, 39202, United States

Location

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, 87110, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Monument Health Rapid City Hospital, Inc.

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hillary Overholser

  Zimmer Biomet Assoc Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2034
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)