Clinical Trial: Cutaneous and Systemic Reactions to Metal Implants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cutaneous and Systemic Reactions to Metal Implants: Utility of Patch Testing Prior and Post Placement of Metal Orthopedic Implants

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 Summary:

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.


Sponsor: Winthrop University Hospital

Current Primary Outcome:

  • 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
  • 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. ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Winthrop University Hospital

Dates:
Date Received: June 17, 2015
Date Started: August 2014
Date Completion: August 2018
Last Updated: October 31, 2016
Last Verified: October 2016