DRKS00031567尚未招募不适用

Whole blood, bone marrow and synovial fluid metal concentrations in children and adolescents with versus without osteosynthesis devices or/and arthroplasty impants in situ - a multicenter pilot study - YMCA (Youth Metal Concentration Analyses)

Zentrum für Orthopädie, Unfallchirurgie und Rehabilitationsmedizin, Universitätsmedizin Greifswald0 个研究点目标入组 6,000 人开始时间: 2023年3月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•(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

•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
•(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

发起方

Zentrum für Orthopädie, Unfallchirurgie und Rehabilitationsmedizin, Universitätsmedizin Greifswald