Cutaneous and Systemic Reactions to Metal Implants

NCT02483728 | Terminated

• 1 other identifier: WUH 14318
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Dermatitis, Allergic Contact

Keywords

Metal Allergy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

• 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.

Study Arms (2)

Metal Allergy Hx +, Metal Patch Test +

OTHER

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

Metal Allergy Hx +, Metal Patch Test -

OTHER

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

Interventions

Patch Test OTHER

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 +; Metal Allergy Hx +, Metal Patch Test -

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder)
• Able to undergo patch testing

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Smart Practice: collaborator

Study Sites (2)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• 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.

  PMID: 24934108 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Marcella Aquino, MD

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 29, 2015
• Study Start: August 1, 2014
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

US (2)