Metallosis on Tissues and Serum Metal Levels in Children

• Conditions: Retained Metal Implant; Orthopedic Disorder

• Registration Number: NCT03359109
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study Start: 2017-12-01
• Study First Posted: 2017-12-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Concomitant infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mechanistic responses of bone repair cells upon Ti exposure	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

Secondary Outcome Measures

Name	Time	Method
Evaluate serum levels of metal ions	3-6 months	To evaluate systemic effects of metal ions on children, the investigators will determine whether metal ion levels are elevated in participants with retained implants by intraoperatively blood draw and at first postoperatively visit. Conversely, participants undergoing implant placement will also have ion levels taken intraoperatively and then at latest follow-up visit to see if implants cause in increase in serum metal levels

Trial Locations

Locations (2)

Sanford Health; 🇺🇸 Sioux Falls, South Dakota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States