Nickel-Free vs Standard Knee Implants for Allergy
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo total knee arthroplasty with either nickel-free or standard cobalt chromium components
Follow-up
Participants are monitored for safety, effectiveness, and complications after surgery
Treatment Details
Interventions
- TKA with nickel free components
- TKA with standard cobalt chromium components
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor