MedTrace Logo

Nickel Sensitivity

NCT04058743 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Knee Arthropathy
  • Allergic Reaction

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

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2024-12-11
Completion
2024-12-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058743 on ClinicalTrials.gov