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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 : February 6, 2019
Sponsor:
Collaborator:
Smart Practice
Information provided by (Responsible Party):
New York University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 17, 2015
First Posted Date  ICMJE June 29, 2015
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02483728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cutaneous and Systemic Reactions to Metal Implants
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Dermatitis, Allergic Contact
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Patch Test
  • 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.
    Intervention: Other: Patch Test
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marcella Aquino, MD 516-663-2097 marcella.aquino@nyulangone.org
Contact: Luz Fonacier, MD 516-663-2097 luz.fonacier@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483728
Other Study ID Numbers  ICMJE WUH 14318
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York University School of Medicine
Study Sponsor  ICMJE New York University School of Medicine
Collaborators  ICMJE Smart Practice
Investigators  ICMJE
Principal Investigator: Marcella Aquino, MD NYU Winthrop Hospital
PRS Account New York University School of Medicine
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP