Study 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.
Eligible Conditions
- Knee Arthritis
- Allergy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 10 years
10 years
Estrogen Replacement Therapy
Knee Society Score (KSS)
Radiographic assessment for proper component alignment and any signs of loosening
90 days
Complications
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
TKA with standard cobalt chromium components
1 of 2
TKA with nickel free components
1 of 2
Active Control
Experimental Treatment
90 Total Participants · 2 Treatment Groups
Primary Treatment: TKA with nickel free components · No Placebo Group · N/A
TKA with nickel free components
Device
Experimental Group · 1 Intervention: TKA with nickel free components · Intervention Types: DeviceTKA with standard cobalt chromium components
Device
ActiveComparator Group · 1 Intervention: TKA with standard cobalt chromium components · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
388 Previous Clinical Trials
152,606 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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
Conditions
Cancer Related
Treatments