NCT02483728

Cutaneous and Systemic Reactions to Metal Implants

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dermatitis, Allergic Contact

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-06-05
• Completion: 2018-06-05
• First posted: 2015-06-29
• Last updated: 2020-01-14

Locations

2 sites across 1 country: United States