accumulation of arthroplasty implants' wear and corrosion products in cerebrospinal fluid (CSF)
Conditions
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 spinal anesthesia pe
Sponsors
Centrum für Muskuloskeletale Chirurgie, Charité - Universitätsmedizin Berlin, Campus Charité Mitte & Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • written informed consent • age: = 18 years • denial of concurrent participation in interventional trial(s) affecting the German Drug Act ("AMG" / "Arzneimittelgesetz") • scheduled for elective surgery under spinal anesthesia • only for the study group, not for the control group: at least one arthroplasty implant of the hip, knee, ankle, shoulder or elbow joint in situ • only for the control group: no arthroplasty implant of the hip, knee, ankle, shoulder or elbow joint in situ; matched on age (+/- 5 years) and sex with the study group
Exclusion criteria
Exclusion criteria: • no written informed consent • incapability to give informed consent • symptomatic heart failure NYHA = III • symptomatic heart valve disease = II° • hepatic insufficiency CHILD = B • acute or chronic renal failure necessitating dialysis • history of current or previous alcohol or other drug abuse • psychiatric disorder • sepsis • prevalence of contraindications of lumbar puncture or spinal anesthesia
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). | — |
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, Charité - Universitätsmedizin Berlin, Campus Charité Mitte & Campus Virchow-Klinikum
Outcome results
None listed