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Orthopedic Implant
Persona Partial Knee Replacement for Osteoarthritis
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 at least 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing a new knee replacement system to see how well it works and how long it lasts.
Who is the study for?
This trial is for adults over 18 who need a knee replacement due to conditions like osteoarthritis or tibial plateau fracture and are suitable for the Persona Partial Knee system. Participants must be able to follow the study plan and give informed consent. Those with severe bone or joint issues, certain neurological disorders, infections, inflammatory diseases, or pregnant women cannot join.Check my eligibility
What is being tested?
The study aims to collect data on how well the Persona Partial Knee system works in patients needing knee arthroplasty. It will look at how long the implant lasts (implant survivorship) and measure patient outcomes after surgery using this specific knee replacement device.See study design
What are the potential side effects?
While not specified here, typical side effects of knee replacement may include pain at the surgery site, swelling, stiffness in the knee joint, bleeding or blood clots. There could also be risks related to anesthesia during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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
Secondary outcome measures
EQ-5D
Trial Design
1Treatment groups
Experimental Treatment
Group I: PPK subjectsExperimental Treatment1 Intervention
Subjects that receive the Persona Partial Knee system
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
66,752 Total Patients Enrolled
129 Trials studying Osteoarthritis
32,481 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,359 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,508 Patients Enrolled for Osteoarthritis
Hillary OverholserStudy DirectorZimmer Biomet
10 Previous Clinical Trials
2,057 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,519 Patients Enrolled for Osteoarthritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My bones are too weak to support a medical implant.I have a joint that cannot straighten more than 15 degrees.I have rheumatoid arthritis or another type of joint inflammation.I have infections that could spread to the surgery area.I have weak or damaged tissue around my knee.I am 18 years old or older.I am eligible for knee replacement surgery based on my medical history and physical exam.My knee ligaments are too weak to support a new device.I am willing and able to follow the study's schedule and check-ups.I am eligible for knee replacement surgery based on my doctor's assessment.I am eligible for a Persona Partial Knee replacement outside of this study.I am able to follow directions and cooperate with treatment.My knee bends inward and cannot be straightened out manually beyond 15 degrees.I do not have an infection, sepsis, or bone infection.I have Charcot's disease.I have deep damage in the weight-bearing area of my opposite joint.I have issues with blood flow, muscle loss, or nerve and muscle diseases.I have a condition that could affect bone growth.I have been diagnosed with osteomalacia.
Research Study Groups:
This trial has the following groups:- Group 1: PPK subjects
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.
Is enrollment still open for this trial?
"The trial's information on clinicaltrials.gov has indicated that it is not currently recruiting candidates, as the posting was first made in February 2017 and last updated in April 2022. However, there are 972 other trials seeking patients at this present time."
Answered by AI
How widespread is the availability of this medical trial in North America?
"This medical trial is currently taking place at Panorama Orthopedics & Spine Center in Golden, Colorado, Sah Orthopaedic Associates in Fremont, California and Skagit Regional Clinics-Riverbend in Mount Vernon, Washington with additional sites located throughout the United States."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Washington
How old are they?
18 - 65
What site did they apply to?
Sah Orthopaedic Associates
Skagit Regional Clinics-Riverbend
What portion of applicants met pre-screening criteria?
Met criteria
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