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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxford Knee Score (OKS)
Secondary study objectives
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
Frequency and types of Adverse Events
Numeric Rating Scale (Pain)
+3 more
Other study objectives
Operative Room Time

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
375 Previous Clinical Trials
67,717 Total Patients Enrolled
135 Trials studying Osteoarthritis
34,387 Patients Enrolled for Osteoarthritis

Media Library

Cemented Persona Knee System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05630053 — N/A
Osteoarthritis Research Study Groups: Cemented Persona Keel Knee System, Cementless Persona Keel Knee System
Osteoarthritis Clinical Trial 2023: Cemented Persona Knee System Highlights & Side Effects. Trial Name: NCT05630053 — N/A
Cemented Persona Knee System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630053 — N/A
~200 spots leftby May 2032
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