Knee Pain ChronicTKANCT04817969
Persona Ti-Nidium Post-Market Clinical Follow-up
A study testing Zimmer Biomet Persona Ti-Nidium Total Knee System in people with Knee Pain Chronic and Osteoarthritis, run by Zimmer Biomet at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Zimmer Biomet Persona Ti-Nidium Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jun 2021to May 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, 87110
Duke University
Durham, North Carolina, 27708
MedStar Health Research Institute
Hyattsville, Maryland, 20782
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202
Denver Hip & Knee, Inc.
Parker, Colorado, 80134
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, 57701
About this study
Official title: 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.
Read the 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:
- Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium total knee system and instrumentation in primary and revision TKA.
- 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).
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Varus Deformity
- Being tested
- Zimmer Biomet Persona Ti-Nidium Total Knee System
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Biomet Persona Ti-Nidium Total Knee SystemDevice
Primary Knee Total Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Persona Ti-Nidium | Other | Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System Receives: Device: Zimmer Biomet Persona Ti-Nidium Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (2)
Knee Society Score (KSS) Expectations (pre and post op)
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.
Measured: 10 years
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jun 2021
- Primary completionMay 2034 (estimated)
- Study completionMay 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet Assoc Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817969
- Sponsor's protocol ID
- CMG2020-05K
- Acronym
- TKA
- Status last verified
- Oct 2025
- First submitted
- 23 Mar 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No