Cutaneous and Systemic Reactions to Metal Implants

NYU Langone Health6 enrolled

Overview

The purpose of this study is to evaluate if metal patch testing in metal allergic patients is useful for predicting the development of allergic skin disease or systemic symptoms in patients who recieve a metal orthopedic implant.

This prospective cohort study will enroll patients with a history of metal allergy who require implantation of a metal orthopedic device. Patients will be followed for one year after surgery to determine if any symptoms including rash, itch, joint pain, joint swelling, and/or joint failure develop post implantation. Patients will be recruited from two sites: (1) Divisions of Orthopedics and Allergy \& Immunology, Winthrop University Hospital, and (2) Division of Immunology, and Allergy Section, University of Cincinnati Medical Center.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Dermatitis, Allergic Contact

Interventions

Patch TestOTHER

Patch testing is a technique used to diagnose an allergic skin disease called allergic contact dermatitis. It attempts to reproduce in small scale allergic reactions of the skin from things that come in contact with it.This is the standard of care to determine allergic contact dermatitis.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder) 2. Able to undergo patch testing Exclusion Criteria 1. Patients on oral immunosuppressant medications within 4 weeks of patch testing or topical corticosteroids to the back within 1 week of patch testing 2. Patients who are pregnant or breastfeeding

Locations (2)

Winthrop University Hospital

Mineola, New York, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

The development of rash assessed via a patient and physician questionnaire asking to answer yes or no to the following questions: Do you have new onset of itchy rash above the implant site? Do you have new onset of generalized itchy rash?

Type of rash that has developed: eczema above implant, generalized eczema, urticaria, vasculitis

Time frame: Change from baseline physical exam prior to surgery (development of rash) at 4-6 weeks post date of surgery, 3 months post surgery, 6 months post surgery and one year post surgery.

The development of joint pain or joint swelling assessed via a patient and physician questionnaire asking to answer yes or no to the following questions: Do you have pain at the site of your implant? Does the patient have atypical joint swelling?

Time frame: Change from baseline physical exam prior to surgery at 4-6 weeks post date of surgery, 3 months post surgery, 6 months post surgery and one year post surgery.

Data from ClinicalTrials.gov

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