Systemic Metal Ion Concentrations in Patients with Modular Megaprostheses

• Conditions: bonetumors; Sarcoma; 10005959

• Registration Number: NL-OMON45380
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

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

-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<60
-Patient refusal to participate in the study
-Likely problems, in the judgement of the investigator, with maintaining follow-up

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(1) Serum metal ion concentrations of Silver (Ag), Cobalt (Co), Chrome (Cr),<br /><br>Molybdenum (Mo), Titanium (Ti), Aluminium (Al), Vanadium (V) during follow up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) Adverse effects (metallosis, osteolysis, periprosthetic loosening,<br /><br>pseudotumour formation and argyria) (2) Quality of life and functional status<br /><br>using SF-36 and TESS.</p><br>