Nickel Sensitivity

Stopped early · Not applicable

Conditions studied: Knee Arthropathy, Allergic Reaction

In brief

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.

Key facts

Study ID

NCT04058743

Run by

Rush University Medical Center

People needed

9

Starts

2019-09-27

Expected to finish

2024-12-21

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients less than 18 years of age
• Patients undergoing revision TKA
• Non english speaking patients
• Patient who have medical comorbidities that prevent elective TKA

Where it is running

• Rush University medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.