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Orthopedic Implant

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 18-75 years of age, inclusive
Patient qualifies for primary total knee arthroplasty based on physical exam and medical history
Must not have
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
Severe instability secondary to the absence of collateral ligament integrity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the Persona knee implant to see how well it works and how long it lasts.

Who is the study for?
This trial is for adults aged 18-75 with severe knee pain and disability due to conditions like osteoarthritis or rheumatoid arthritis, among others. Candidates must need a total knee replacement, be able to consent, and commit to follow-up evaluations. Exclusions include those in other studies, with certain bone/muscle diseases, previous knee replacements on the same side, or infections affecting the joint.
What is being tested?
The study aims to collect data on the performance of Persona fixed bearing knee implants used in total knee arthroplasty (knee replacement surgery). It will focus on how long the implant lasts (implant survivorship) and how well it works clinically for patients who receive it.
What are the potential side effects?
While not specified here, typical side effects from similar surgeries may include pain at the surgery site, swelling around the knee area, infection risk at incision sites or inside the joint space itself. There might also be risks related to anesthesia during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am eligible for a knee replacement based on my doctor's assessment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have osteoporosis or a condition affecting my muscles or nerves that impacts my limb.
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My joint is very unstable because of damaged ligaments.
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I have had knee replacement surgery on the same side before.
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My bones in the leg are too weak for surgery.
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My bones are still growing.
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I have joint damage due to nerve problems.
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My joint fusion surgery has healed well and I don't feel pain.
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I have rheumatoid arthritis with skin ulcers or recurrent skin issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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
Knee Society Score
Secondary study objectives
EQ-5D

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: PERSONA TKAExperimental Treatment1 Intervention
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimmer Persona Total Knee System
2013
N/A
~300

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
378 Previous Clinical Trials
67,346 Total Patients Enrolled
136 Trials studying Osteoarthritis
33,829 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,243 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,976 Patients Enrolled for Osteoarthritis

Media Library

Zimmer Persona Total Knee System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT02255383 — N/A
Osteoarthritis Research Study Groups: PERSONA TKA
Osteoarthritis Clinical Trial 2023: Zimmer Persona Total Knee System Highlights & Side Effects. Trial Name: NCT02255383 — N/A
Zimmer Persona Total Knee System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02255383 — N/A
~59 spots leftby Dec 2025
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