Systemic Metal Ion Concentrations in Patients with Modular Megaprostheses

Systemic Metal Ion Concentrations in Patients with Modular Megaprostheses - Metal Ions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45380

Enrollment

Registered

2017-07-10

Start date

2017-03-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

bonetumors Sarcoma

Interventions

Ions

Limb Salvage

Megaprostheses

Metal

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: -Males and females, 18 years of age or older -Primary treatment by endoprosthetic reconstruction with a MUTARS modular megaprosthesis (all types of MUTARS, including expandable prostheses, are acceptable) -Provision of informed consent

Exclusion criteria

Exclusion criteria: -Revision surgery of any type of metallic prosthesis -Anamnestic use of metal containing nutritional supplements or medications -Contact with metal ions in the work environment -Renal insufficiency defined as an eGFR

Design outcomes

Primary

Measure	Time frame
(1) Serum metal ion concentrations of Silver (Ag), Cobalt (Co), Chrome (Cr), Molybdenum (Mo), Titanium (Ti), Aluminium (Al), Vanadium (V) during follow up.	—

Secondary

Measure	Time frame
(1) Adverse effects (metallosis, osteolysis, periprosthetic loosening, pseudotumour formation and argyria) (2) Quality of life and functional status using SF-36 and TESS.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)