Cutaneous and Systemic Reactions to Metal Implants
Primary Purpose
Dermatitis, Allergic Contact
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patch Test
Sponsored by
About this trial
This is an interventional screening trial for Dermatitis, Allergic Contact focused on measuring Metal Allergy
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder)
- Able to undergo patch testing
Exclusion Criteria
- Patients on oral immunosuppressant medications within 4 weeks of patch testing or topical corticosteroids to the back within 1 week of patch testing
- Patients who are pregnant or breastfeeding
Sites / Locations
- Winthrop University Hospital
- University of Cincinnati College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Metal Allergy Hx +, Metal Patch Test +
Metal Allergy Hx +, Metal Patch Test -
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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?
Secondary Outcome Measures
Full Information
NCT ID
NCT02483728
First Posted
June 17, 2015
Last Updated
January 10, 2020
Sponsor
NYU Langone Health
Collaborators
Smart Practice
1. Study Identification
Unique Protocol Identification Number
NCT02483728
Brief Title
Cutaneous and Systemic Reactions to Metal Implants
Official Title
Cutaneous and Systemic Reactions to Metal Implants: Utility of Patch Testing Prior and Post Placement of Metal Orthopedic Implants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Smart Practice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Allergic Contact
Keywords
Metal Allergy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metal Allergy Hx +, Metal Patch Test +
Arm Type
Other
Arm Description
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.
Arm Title
Metal Allergy Hx +, Metal Patch Test -
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patch Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
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?
Description
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder)
Able to undergo patch testing
Exclusion Criteria
Patients on oral immunosuppressant medications within 4 weeks of patch testing or topical corticosteroids to the back within 1 week of patch testing
Patients who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcella Aquino, MD
Organizational Affiliation
NYU Winthrop Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24934108
Citation
Pinson ML, Coop CA, Webb CN. Metal hypersensitivity in total joint arthroplasty. Ann Allergy Asthma Immunol. 2014 Aug;113(2):131-6. doi: 10.1016/j.anai.2014.05.012. Epub 2014 Jun 13.
Results Reference
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Cutaneous and Systemic Reactions to Metal Implants
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