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Cutaneous and Systemic Reactions to Metal Implants

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ClinicalTrials.gov Identifier: NCT02483728
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Smart Practice
Information provided by (Responsible Party):
Marcella Aquino, MD, Winthrop University Hospital

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Allergic Contact Other: Patch Test Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cutaneous and Systemic Reactions to Metal Implants: Utility of Patch Testing Prior and Post Placement of Metal Orthopedic Implants
Actual Study Start Date : August 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Metal Allergy Hx +, Metal 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.
Other: Patch Test
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.

Metal Allergy Hx +, Metal 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.
Other: Patch Test
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 Measures :
  1. 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? [ 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. ]
    Type of rash that has developed: eczema above implant, generalized eczema, urticaria, vasculitis

  2. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483728


Contacts
Contact: Marcella Aquino, MD 516-663-2097 maquino@winthrop.org
Contact: Luz Fonacier, MD 516-663-2097 lfonacier@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Marcella R Aquino, MD    516-663-2097    maquino@winthrop.org   
Contact: Luz Fonacier, MD    516-663-2097    lfonacier@winthrop.org   
Sub-Investigator: Luz Fonacier, MD         
Principal Investigator: Marcella Aquino, MD         
Sub-Investigator: Mark Davis-Lorton, MD         
United States, Ohio
University of Cincinnati College of Medicine Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Jonathan Bernstein, MD    513-558-5533    jonathan.bernstein@uc.edu   
Sponsors and Collaborators
Winthrop University Hospital
Smart Practice
Investigators
Principal Investigator: Marcella Aquino, MD Winthrop University Hospital

Publications:
Responsible Party: Marcella Aquino, MD, Attending, Assistant Professor of Medicine, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT02483728     History of Changes
Other Study ID Numbers: 14318
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Marcella Aquino, MD, Winthrop University Hospital:
Metal Allergy

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Skin Diseases
Dermatitis, Contact
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases