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临床试验/NCT03359109
NCT03359109Enrolling By Invitation不适用

Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Mayo Clinic
入组人数
50
试验地点
2
主要终点
Mechanistic responses of bone repair cells upon Ti exposure

研究概览

简要总结

Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.

详细描述

Metal implants are routinely placed in children for treatment of fracture or deformity. Long-term effects of indwelling metal implants are not well-understood. Data from this study will provide guidances as to whether some metals are safer for children (stainless vs. titanium alloys). In addition, we will document the presence of serum ion concentration for children with metal implants in place and whether this resolves after implant removal. Tissues adjacent to implants will be evaluated for signs of metallosis and wear debris. Presence of metallosis will be correlated with serum ion concentration. In vivo studies will provide data on whether metal exposure to bone cells and fibroblasts affects their inflammatory cascade and function. Based on these findings, surgeons can better counsel patients whether routine implant removal is advisable or whether stainless steel implants are safer for long-term retention compared to titanium implants. Further, novel drug targets for treatment and prevention of metallosis will be developed. This project will foster collaboration and future partnerships between the Sanford Health and Mayo Clinic research teams

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 4 years - 18 years
  • Stainless steel, titanium or titanium-alloy based implants, scheduled for surgery
  • De novo surgery where titanium implant placement

排除标准

  • Concomitant infection

结局指标

主要结局

Mechanistic responses of bone repair cells upon Ti exposure

时间窗: 3-6 months

To address how deregulated bone repair provokes adverse reactions, the investigators will monitor gene regulatory effects in cell culture models of titanium exposure by either silencing or activating key biological pathways

次要结局

  • Evaluate serum levels of metal ions(3-6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Noelle Larson, MD

Associate Professor of Orthopedics

Mayo Clinic

研究点 (2)

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