adverse reactions to metal debris (ARMD), i.e. particles and corrosion products, released from orthopaedic implants, including bone cement spacers periprosthetic osteolyses periprosthetic infection T84.7 T84.9 M89.5
Conditions
Interventions
Group 1: Static knee spacer:
In the course of implantation and of explantation of the static knee spacer local tissues (synovial fluid, synovial membrane, periimplant membrane/ soft tissue and bone)
Sponsors
Universitätsklinikum Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients of all sexes who receive an articulating or a static knee spacer at one of the study centers and give written consent to participate in this study
Exclusion criteria
Exclusion criteria: age < 18 years, lack of written informed consent, lacking capacity of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. In order to systematically investigate local Zr exposure, the following questions are addressed: (1) Can Zr be detected in the synovium, synovial membrane, peri-implant membrane and bone sampled during reimplantation if a spacer made of bone cement containing zirconium dioxide was used? (2) At what concentration and amount can it be detected in synovium / membrane and bone? (3) What are the particle sizes and are these particles PMMA-bound? 2. Biological consequences of local exposure to Zr: The following questions are addressed: (1) Does in vitro exposure to Zr-containing particles induce enhanced osteoclastic differentiation of primary human macrophages from the human bone marrow and does this exposure lead to enhanced osteoclastic activity? (2) Are human mesenchymal stromal cells from human bone marrow influenced in their capacity to differentiate into matrix mineralizing osteoblasts following exposure to these particles? 3. In order to systematically investigate a possible systemic exposure to Zr, the following questions are raised: (1) Can systemic exposure to Zr be detected at different time points during spacer usage if zirconium dioxide containing bone cement is used as spacer component? (2) In what concentration and quantity can it be detected systemically? (3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In order to systematically investigate local Zr exposure, the following questions are addressed: (4) To what depth from the articular surface can it be detected in bone? Does the concentration change with increasing distance from the joint space? (5) Is there a difference between articulating and static knee spacers with respect to the questions 1.(1)-(4)? 2. In order to systematically investigate a possible systemic exposure to Zr, the following question is raised: Is there a difference between articulating and static knee spacers regarding 3.(1) and 3.(2)? | — |
Countries
Germany
Contacts
Public ContactAnastasia Rakow
Zentrum für Orthopädie, Unfallchirurgie und Rehabilitationsmedizin, Universitätsmedizin Greifswald
Outcome results
None listed