Metallosis on Tissues and Serum Metal Levels in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Orthopedic Disorder Retained Metal Implant

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Stainless Steel Devices

10 patients with stainless steel devices implanted

No interventions assigned to this group

Titanium or Titanium-alloy Based Devices

30 patients with titanium or titanium-alloy implanted devices

No interventions assigned to this group

De Novo Titanium Implant

10 patients undergoing de novo titanium implant placement who have had no previous orthopedic procedures

No interventions assigned to this group

Eligibility Criteria

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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