Cutaneous and Systemic Reactions to Metal Implants: Utility of Patch Testing Prior and Post Placement of Metal Orthopedic Implants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- 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?
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder)
- •Able to undergo patch testing
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Patch Test (Other)
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.
干预措施: Patch Test (Other)
结局指标
主要结局
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?
时间窗: 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.
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?
时间窗: 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
次要结局
未报告次要终点