What this study is
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.
Study details
- Official title
- Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants
- Sponsor
- Mayo Clinic
- Conditions
- Orthopedic Disorder · Retained Metal Implant
- Enrolling
- 50 people
- Starts
- 2017-12-01
- Est. completion
- 2026-09
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 4 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Ages 4 years - 18 years
- Stainless steel, titanium or titanium-alloy based implants, scheduled for surgery
- De novo surgery where titanium implant placement
You can't join if
- Concomitant infection
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openMayo Clinic
Rochester, Minnesota, United States
Sanford Health
Sioux Falls, South Dakota, United States
Study team
Sponsor
Mayo Clinic
Study ID 17-004970
Principal investigator
A.Noelle Larson, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.