8 Participants Needed

Nickel-Free vs Standard Knee Implants for Allergy

CJ
AD
Overseen ByAnne DeBenedetti, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants. The hypothesis is that patients with a self-reported nickel sensitivity will have similar patient reported outcome scores compared to those patients without reported nickel sensitivity. Therefor the anticipation is for there to be no differences in other clinical outcome measures or functional outcome scores between the two cohorts.

Eligibility Criteria

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.

Inclusion Criteria

I am having a knee replacement due to arthritis and I am allergic to nickel.

Exclusion Criteria

I have health issues that prevent me from having knee replacement surgery.
Non english speaking patients
I am under 18 years old.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with either nickel-free or standard cobalt chromium components

1-2 weeks
1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety, effectiveness, and complications after surgery

10 years
Regular follow-up visits with radiographic assessments

Treatment Details

Interventions

  • TKA with nickel free components
  • TKA with standard cobalt chromium components
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security