Systemic nickel and chromium burden after osteosynthesis for pediatric extremity fractures - a prospective monocentric study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034133

Enrollment

Registered

2024-05-24

Start date

2024-07-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S52.2 S52.3 S42.4 S52.5

Interventions

Group 1: ESIN osteosynthesis for upper extremity fractures (n= 22) Group 2: K-wire osteosynthesis for upper extremity fractures (n= 22)

Eligibility

Sex/Gender

All

Age

No minimum to 16 Years

Inclusion criteria

Inclusion criteria: Presence of a fracture of the upper- or forearm requiring treatment with metal ESIN or K-wires, age =16 years, consent to participate in the study, complete data set (including availability of initial and follow-up values for urine and blood parameters)

Exclusion criteria

Exclusion criteria: Metal allergy, adolescents >16 years of age, presence of a systemic disease or kidney- and/or liver-disease, declined consent

Design outcomes

Primary

Measure	Time frame
systemic and urinary nickel and chromium burden prior to and after metal implantation	—

Secondary

Measure	Time frame
i.e., body weight and length, surface of metal implant, metal implant duration,...	—

Countries

Germany

Contacts

Public ContactMatthias Nissen

Klinik für Kinderchirurgie

matthias.nissen@rub.de+4923021733709

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026