New approaches in the development of Hypoallergenic implant material in Orthopaedics: Steps to personalised medicine

New approaches in the development of Hypoallergenic implant material in Orthopaedics: Steps to personalised medicine - HypOrth

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010616

Enrollment

320

Registered

2016-06-09

Start date

2013-08-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T84.0

Interventions

Group 1: 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 rev

Blood, removal of periprosthetic tissue As part of the re-operation of the patients blood and tissue samples are taken in order to gain insights into the reasons for the rejection. All patients in e

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The aims of HypOrth in brief are the following: 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 2. Understanding of mechanisms of adverse immune reaction and develop predictive computational models 3. Finding of predictive biomarkers for application in personalised medicine 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 5. Evaluation of data, production of prototypic hypoallergenic implant	—

Measure

Time frame

The aims of HypOrth in brief are the following: 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 2. Understanding of mechanisms of adverse immune reaction and develop predictive computational models 3. Finding of predictive biomarkers for application in personalised medicine 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 5. Evaluation of data, production of prototypic hypoallergenic implant

—

Countries

Estonia, Germany

Contacts

Public ContactChristoph Lohmann

Otto-von-Guericke University Magdeburg

christoph.lohmann@med.ovgu.de+49-391-6714001

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026