Cutaneous and Systemic Reactions to Metal Implants

Not Applicable

Terminated

• Conditions: Dermatitis, Allergic Contact
• Interventions: Other: Patch Test

• Registration Number: NCT02483728
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-29
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-05
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metal Allergy Hx +, Metal Patch Test -	Patch Test	These are patients with a history of metal allergy who are patch test negative to metals (metal series, metal disc if available from manufacturer, bone cement components and topical antibiotics) prior to implantation of metal device.
Metal Allergy Hx +, Metal Patch Test +	Patch Test	These are patients with a history of metal allergy who are patch test positive to metals (metal series, metal disc if available from manufacturer, bone cement components and topical antibiotics) prior to implantation of metal device.

Primary Outcome Measures

Name	Time	Method
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?	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.
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?	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.	Type of rash that has developed: eczema above implant, generalized eczema, urticaria, vasculitis

Trial Locations

Locations (2)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

University of Cincinnati College of Medicine; 🇺🇸 Cincinnati, Ohio, United States