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Orthopedic Implant
Cemented vs Cementless Knee Implants for Osteoarthritis
N/A
Recruiting
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will study the safety, performance, and benefits of two types of knee implants.
Who is the study for?
This trial is for adults with various knee conditions like arthritis or deformities who need a total knee replacement. Participants must be able to follow the study's procedures and give informed consent. Pregnant individuals, those in other studies, or with mental/neurologic conditions that affect postoperative care are excluded.Check my eligibility
What is being tested?
The trial compares two types of knee replacements: one using cement (Cemented Persona Knee System) and one without (Cementless Persona Knee System). The goal is to assess their safety, performance, and clinical benefits in patients requiring surgery.See study design
What are the potential side effects?
Potential side effects may include pain at the surgery site, swelling, infection risk increase around the implant area, allergic reactions to materials used in knee systems, or complications leading to further surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 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-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
Frequency and types of Adverse Events
Numeric Rating Scale (Pain)
+3 moreOther outcome measures
Operative Room Time
Trial Design
2Treatment groups
Active Control
Group I: Cemented Persona Keel Knee SystemActive Control1 Intervention
Persona Keel Cemented Tibia
Group II: Cementless Persona Keel Knee SystemActive Control1 Intervention
Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia
Find a Location
Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,097 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for knee replacement surgery using the Persona Knee System.I am not institutionalized, a known drug abuser, alcoholic, and I understand what is required in this study.I am not willing to sign the Informed Consent.I am willing and able to follow the study's schedule for check-ups.I am scheduled for knee replacement surgery on both knees at the same time.I am an adult and my bones have stopped growing.
Research Study Groups:
This trial has the following groups:- Group 1: Cemented Persona Keel Knee System
- Group 2: Cementless Persona Keel Knee System
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 participants are being accepted for this clinical trial?
"This medical research necessitates the enrollment of 300 eligible patients. Potential participants can join this trial from places such as Baptist Health South Florida in Coral Gables, FL and Rothman Institute located in Bryn Mawr, PA."
Answered by AI
Is there an ongoing recruitment phase for this experiment?
"Affirmative. The information located on clinicaltrials.gov suggests that this trial is currently enrolling patients. It was initially posted on July 25th, 2023 and has been updated as recently as August 27th of the same year. Altogether 300 individuals need to be recruited from 5 medical centres for the study's success."
Answered by AI
In what number of healthcare facilities is this experiment being conducted?
"At present, this clinical trial has 5 open recruitment sites including Baptist Health South Florida located in Coral Gables, Rothman Institute situated in Bryn Mawr and Lehigh Valley Hospital - Dickson City based in Dickson City. Additionally, there are 2 other locations available for enrolment."
Answered by AI
Who else is applying?
What site did they apply to?
Centura Health
Anderson Orthopaedic Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
First time human, and the idea of receiving help is appealing. Second, if I could do something that would help others it could make me a contributor to my community.
PatientReceived 1 prior treatment
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