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

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 - NeuroWear II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014556

Enrollment

Registered

2018-04-09

Start date

2018-04-18

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

accumulation of arthroplasty implants' wear and corrosion products in cerebrospinal fluid (CSF)

Interventions

Group 1: A CSF (cerebrospinal fluid) sample of patients with at least one major artificial joint (i.e. hip, knee, ankle, shoulder, elbow) in situ is taken in the course of routine lumbar puncture perf

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: - age < 18 years - patients under legal guardianship for medical decision making

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactAnastasia Rakow

Centrum für Muskuloskeletale Chirurgie (CMSC), Charité - Universitätsmedizin Berlin

anastasia.rakow@charite.de030-45050

Outcome results

None listed

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