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TERMINATED
NCT04058743
NA

Nickel Sensitivity

Sponsor: Rush University Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Nickel Sensitivity on Patient Reported Outcomes After Total Knee Arthroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2019-09-27

Completion Date

2024-12-21

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DEVICE

TKA with nickel free components

Patients will be randomized to receive either the standard cobalt chromium components or nickel free components

DEVICE

TKA with standard cobalt chromium components

Patients will be randomized to receive either the standard cobalt chromium components or nickel free components

Locations (1)

Rush University medical Center

Chicago, Illinois, United States