ew approaches in the development of Hypoallergenic implant material in Orthopaedics: Steps to personalised medicine
- Conditions
- T84.0Mechanical complication of internal joint prosthesis
- Registration Number
- DRKS00010616
- Lead Sponsor
- Otto-von-Guericke University MagdeburgUniversitätsklinik für Orthopädie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 419
Inclusion Criteria
I. More than 150 patients with protheses without complications; the immune system does not develop adverse immune response to the implant material; blood
II. More than 150 patients with primary prostheses. Blood collection and removal of the capsule tissue
III. More than 90 patients suspected of having an unwanted immune response and need for revision surgery; Blood, removal of periprosthetic tissue
Exclusion Criteria
none
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aims of HypOrth in brief are the following:<br><br>1. Identification of adverse immune reactions (AIR) to implant material and differentiation of AIR from low-grade infection in the context of prosthesis loosening; inclusion of epidemiological and clinical expertise and the finding of diagnostic biomarkers for AIR<br>2. Understanding of mechanisms of adverse immune reaction and develop predictive computational models<br>3. Finding of predictive biomarkers for application in personalised medicine<br>4. Testing of conventional and new material combinations for implant and coating on different cell systems: bone cells and immune cells for biocompatibility, antibacterial properties and evoking immunological parameters including the newly identified biomarkers<br>5. Evaluation of data, production of prototypic hypoallergenic implant
- Secondary Outcome Measures
Name Time Method