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Implant

Nickel-Free vs Standard Knee Implants for Allergy

N/A
Waitlist Available
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing primary TKA for the diagnosis of osteoarthritis or inflammatory arthritis with self-reported nickel allergy. Patients are routinely asked about nickel sensitivity as a part of the standard pre operative questionnaire already in place.
Be older than 18 years old
Must not have
Patients less than 18 years of age
Patients undergoing revision TKA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two types of knee implants to see if there is a difference in patient reported outcome scores for those with nickel sensitivity.

Who is the study for?
This trial is for adults with knee arthritis who are getting a total knee arthroplasty (TKA) and have self-reported nickel allergies. They must be able to speak English and not have any medical conditions that would prevent them from having elective TKA.
What is being tested?
The study aims to compare the outcomes of patients with nickel sensitivity undergoing knee replacement surgery using either standard cobalt chromium components or nickel-free implants.
What are the potential side effects?
While specific side effects aren't listed, typical risks of knee replacement surgery may include pain, swelling, infection risk at the surgical site, blood clots, and possible reaction to implant materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a knee replacement due to arthritis and I am allergic to nickel.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.
Select...
I am having a second knee replacement surgery.

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 (KSS)
Secondary study objectives
Complications
Estrogen Replacement Therapy
Radiographic assessment for proper component alignment and any signs of loosening

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TKA with nickel free componentsExperimental Treatment1 Intervention
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
Group II: TKA with standard cobalt chromium componentsActive Control1 Intervention
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
439 Previous Clinical Trials
250,156 Total Patients Enrolled

Media Library

TKA with nickel free components (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04058743 — N/A
Allergy Research Study Groups: TKA with nickel free components, TKA with standard cobalt chromium components
Allergy Clinical Trial 2023: TKA with nickel free components Highlights & Side Effects. Trial Name: NCT04058743 — N/A
TKA with nickel free components (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058743 — N/A
~15 spots leftby Dec 2025
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