T56.9 Z96.6 T84.9 Z47.0 T56.8
Conditions
Interventions
Group 1: Patients who have at least one metal orthopaedic implant (e.g. screw/s, wire/s, plate/s, nail/s, arthroplasty implant/s) in situ.
(Patients with "relevant implant status")
Analyses of whole
Sponsors
Zentrum für Orthopädie, Unfallchirurgie und Rehabilitationsmedizin, Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) for prospective collection of data and biomaterials: • every patient (f/m/d) of any age who is scheduled to undergo surgery or/and a blood draw in the course of clinical routine at one of the study centers • written informed consent of the legal custodian or – in case of legal age and empowerment – written informed consent of the patient • only for the study group (Arm 1): at least one (paediatric) orthopaedic implant in situ b) for retrospective data collection: • every patient (f/m/d) of any age who underwent blood (whole blood or serum) metal ion concentration analysis / analyses in the past in the course of clinical routine (e.g. “monitoring” of blood metal levels in patients with growing implants in situ (such as growing rods for scoliosis treatment) • as conformable to law / in consideration of legal regulations in force at the respective study center (Greifswald/Mecklenburg-Vorpommern (Germany); Berlin (Germany); Graz (Austria)): written informed consent of the legal custodian or – in case of legal age and empowerment – written informed consent of the patient: (a) for pseudonymised / anonymised usage of the patient’s data obtained in the course of clinical routine (i.e. diagnostics and/or therapies) at the respective university medicine center for institutional research OR (b) for inclusion of the patient’s pseudonymised / anonymised data in this study • only for the study group (Arm 1): at least one (paediatric) orthopaedic implant in situ
Exclusion criteria
Exclusion criteria: a) for prospective collection of data and biomaterials: • lack of (valid) written informed consent of the legal custodian or – in case of legal age and empowerment – written informed consent of the patient • concurrent participation in a Medicinal Products Act (AMG) study • concurrent participation in a Medical Device Regulation (MDR) study b) for retrospective data collection: • as conformable to law / in consideration of legal regulations in force at the respective study center (Greifswald/Mecklenburg-Vorpommern (Germany); Berlin (Germany); Graz (Austria)): lack of (valid) written informed consent of the patient / the patient’s legal custodian: (a) for pseudonymized / anonymized usage of the patient’s data obtained in the course of clinical routine (i.e. diagnostics and/or therapies) at the respective university medicine center for institutional research OR (b) for inclusion of the patient’s pseudonymized / anonymized data in this study conformable to law / legal regulations in force at the respective study center (Greifswald/Mecklenburg-Vorpommern (Germany); Berlin (Germany); Graz (Austria)): • effective revocation of consent to participate in this study • effective revocation of consent to usage of the patient’s pseudonymized / anonymized data for institutional research • concurrent participation in a Medicinal Products Act (AMG) study • concurrent participation in a Medical Device Regulation (MDR) study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints include cobalt- (Co), chromium- (Cr), titanium- (Ti), vanadium- (V), aluminum- (Al), molybdenum- (Mo), nickel- (Ni), niobium- (Nb), zirconium- (Zr), manganese- (Mn) and tantalum- (Ta) concentrations in whole blood, bone marrow / cancellous bone and synovial fluid of children and adolescents with and without relevant implant status. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points include the establishment of reference values for cobalt- (Co), chromium- (Cr), titanium- (Ti), vanadium- (V), aluminum- (Al), molybdenum- (Mo), nickel- (Ni), niobium- (Nb), zirconium- (Zr), manganese- (Mn) and tantalum- (Ta) concentrations in whole blood of children and adolescents. Further secondary end points include the characterization of metals (possibly) released from paediatric orthopaedic implants, as well as of the local and systemic cellular immune status of patients with versus without elevated metal concentrations. | — |
Countries
Austria, Germany
Contacts
Public ContactAnastasia Rakow
Zentrum für Orthopädie, Unfallchirurgie und Rehabilitationsmedizin, Universitätsmedizin Greifswald
Outcome results
None listed