Cutaneous and Systemic Reactions to Metal Implants

Dermatitis, Allergic Contact Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02483728
• Other study ID #: WUH 14318
• Status: Terminated
• Phase: N/A
• Start date: August 2014
• Est. completion date: June 5, 2018

Study information

• Verified date: January 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Allergic Contact

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Winthrop University Hospital	Mineola	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Smart Practice

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.