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Orthopedic Implant
Titanium Knee Implant for Knee Arthritis (TKA Trial)
N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is of legal age and skeletally mature
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
TKA Trial Summary
This trial will test how well a new titanium knee implant works and how safe it is.
Who is the study for?
This trial is for adults with various knee conditions like osteoarthritis, rheumatoid arthritis, and chronic knee pain who need a total knee replacement. Participants must be able to consent and follow the study's procedures. Those with mental conditions affecting treatment adherence or at high risk as determined by the investigator are excluded.Check my eligibility
What is being tested?
The Persona Ti-Nidium Total Knee System is being tested for its effectiveness and safety in total knee arthroplasty (knee replacement surgery). The study aims to assess how well this implant works over time in patients undergoing surgery.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include pain at the surgical site, swelling, infection risks associated with surgeries, issues with implant fitting or durability, and possible allergic reactions to materials.
TKA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult and my bones have stopped growing.
Select...
I am eligible for a knee replacement using specific materials based on my medical history and physical exam.
TKA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxford Knee Score (OKS)
Secondary outcome measures
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
Knee Society Score (KSS) Expectations (pre and post op)
TKA Trial Design
1Treatment groups
Experimental Treatment
Group I: Persona Ti-NidiumExperimental Treatment1 Intervention
Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,155 Total Patients Enrolled
129 Trials studying Osteoarthritis
32,884 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorClinical Affairs Director
15 Previous Clinical Trials
3,762 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,911 Patients Enrolled for Osteoarthritis
Hillary OverholserStudy DirectorZimmer Biomet Assoc Director
10 Previous Clinical Trials
2,460 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,922 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for a specific knee replacement surgery.I am willing and able to follow the study's schedule for check-ups.I am not willing to sign the Informed Consent.I am an adult and my bones have stopped growing.I am eligible for a knee replacement using specific materials based on my medical history and physical exam.I am not institutionalized, a known drug abuser, alcoholic, and I understand the study requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Persona Ti-Nidium
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are receiving treatment as part of this research?
"This study requires 240 individuals that satisfy the inclusion criteria. These enrollees can be recruited from prominent medical centres such as MedStar Health Research Institute in Hyattsville, Maryland and Duke University in Durham, North carolina."
Answered by AI
How many practitioners are currently administering this trial?
"The MedStar Health Research Institute in Hyattsville, Maryland; Duke University in Durham, North carolina; and Monument Health Rapid City Hospital, Inc. in Rapid City, South dakota are the primary sites of this trial along with four other additional medical centres."
Answered by AI
Are there any open slots to participate in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, first posted on June 1st 2021, is actively searching for participants. Approximately 240 individuals are needed to be recruited from 4 distinct locations."
Answered by AI
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