Cutaneous and Systemic Reactions to Metal Implants | NCT02483728 | Trialant

Cutaneous and Systemic Reactions to Metal Implants | NCT02483728 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24934108	Background	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.

Condition Browse Module

Intervention Browse Module