Assessment of metal concentrations in cerebrospinal fluid, whole blood and serum of patients with arthroplasty implants in situ who undergo lumbar puncture in the course of the diagnostic workup or therapy of neurological disease(s) – a pilot study
Recruiting
- Conditions
- accumulation of arthroplasty implants' wear and corrosion products in cerebrospinal fluid (CSF)
- Registration Number
- DRKS00014556
- Lead Sponsor
- Centrum für Muskuloskeletale Chirurgie, Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
age = 18 years
- written informed consent
- scheduled for lumbar puncture in the course of clinical routine (i.e. to rule out or treat neurological diseases / disorders)
- at least one major endoprosthesis (i.e. artificial hip, knee, ankle, shoulder or elbow joint) in situ or respective age- (± 5 years) and sex-matched controls without arthroplasty implant in situ
Exclusion Criteria
- age < 18 years
- patients under legal guardianship for medical decision making
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is an exposure analysis: we aim to investigate whether, and to what extent, metals released by arthroplasty implants accumulate in cerebrospinal fluid (CSF). Primary end points are the concentrations of cobalt (Co), chromium (Cr), titanium (Ti), vanadium (V), aluminum- (Al), molybdenum (Mo), nickel (Ni), niobium (Nb), zirconium (Zr), manganese (Mn), iron (Fe), tantalum (Ta) and strontium (Sr) in CSF of patients with at least one major artificial joint in situ (i.e. hip, knee, ankle, shoulder, elbow) and in CSF of controls without respective arthroplasty implants in situ. Metal analyses will be performed using inductively coupled plasma-mass spectrometry (ICP-MS).<br>
- Secondary Outcome Measures
Name Time Method Secondary end points of this study include the CSF/whole blood ratio and the CSF/serum ratio of the above mentioned metals, and the integrity of the blood-brain barrier (analyses include CSF/serum albumin ratio, S100B in serum and CSF) in patients with at least one major artificial joint in situ and of controls without respective arthroplasty implants in situ.<br>