MgSafe — Promoting patient safety by a novel combination of imaging technologies for biodegradable magnesium implants

Results in brief

Promoting patient safety by a novel combination of imaging technologies for biodegradable magnesium implants

Biomedical imaging has gained a significant technological push and is the mainstay for diagnosis and therapy monitoring. Still, imaging is yet not optimized for the new class of biodegradable Mg-based implants. This class of implant materials serves a demand which rises from ageing populations, an ever-increasing incidence of obesity and a rapid rise in osteoporosis-related fractures, along with increasing high-risk sports activities. So far, these indications are typically treated with non-degradable metal implants, which commonly require surgical removal after complete bone healing. From the health care and patients’ point of view, degradable implants provide a viable, cost-effective, and patient-friendly alternative. From 2013 on, the first degradable metal implant made from a Mg-alloy (compression screw of partner SYN) was CE certified and has been implanted into tens of thousands of patients so far. During the follow-up of Mg-based implants, it became evident that monitoring implant performance and degradation with the existing imaging techniques can be challenging: the contrast is low for X-ray imaging. MR artefacts are induced by the use of conducting metal. PET, IR or ultra-sound imaging are so far not used to study this new class of materials, and the proof of principle has to be given that the modalities can be used at all for these implants. Solving these scientific and technical issues may support a broad clinical acceptance of implantable products made of Mg. The key research objective of MgSafe was and still is to develop and optimise imaging technologies for recently established Mg implants by quantifying their physical impact and suitability for this class of materials in future human applications. Highly sophisticated imaging techniques (nano and micro-computed tomography (nano, µCT), Magnetic Resonance Tomography (MRT), Positron Emission Tomography (PET), Ultrasound and Photoacoustic (USPA), Near Infra-red (NIR) imaging) were developed beyond the forefront of medical device production in vivo and with in situ labelling options to obtain as much information as possible over time. MgSafe delivered non-invasively data on different time and length scales of the body reaction and material behaviour during Mg degradation with a precision and plethora of details, which wasn’t available before.

Data: CORDIS, © European Union

Project objective

Biomedical imaging has gained a significant technological push and is the mainstay for diag-nosis and therapy monitoring. Still, imaging is yet not optimized for the new class of biode-gradable Mg-based implants. MgSafe addresses this point by training 15 ESRs in both, imag-ing and implant technologies. All ESRs will develop their individual Personal Learning Envi-ronment (PLE) and be trained based on the “T-skills concept” in technologies and transferable skills relevant for their career development and prepared to take over leadership positions in an area of tremendous research promises and clinical relevance where the lack for experts is severe and very well recognized.The ESRs will quantify the physical impact and suitability of a variety of modalities on Mg implants. Highly sophisticated imaging techniques (nano and µCT, MRT, PET, USPA, IR) will be developed beyond the forefront of medical device production in vivo and with in situ label-ling options to deliver non-invasively data on different time and length scales of the body reac-tion and material behavior during Mg degradation with a precision and plethora of details which is currently not available. Two Mg-alloys and CE-certified Mg-implants will be studied in rats and sheep. Dummy studies will be performed in parallel (following ASTM rules). The ob-tained multimodal imaging data will be combined with molecular biological/biochemical analy-sis, thereby increasing the information about physiological changes without using additional animals. An additional dimension will be added by the analysis of explants to obtain highest resolution chemical and material science data. All relevant biological and chemical in vivo and ex vivo data will be merged by computational 3D methods, simulations and machine learning approaches. The combination of these results will not only allow for an upscaling of the pro-cesses towards humans but will also deliver valuable data in terms of patient safety.

Original text from CORDIS.

Participants

HELMHOLTZ-ZENTRUM HEREON GMBH · GeesthachtCoordinatorGermany
BRI.TECH GMBH · GrazAustria
CONSIGLIO NAZIONALE DELLE RICERCHE · RomaItaly
FUJIFILM SONOSITE BV · AmsterdamNetherlands
GOETEBORGS UNIVERSITET · GoeteborgSweden
MEDIZINISCHE HOCHSCHULE HANNOVER · HannoverGermany
MEDIZINISCHE UNIVERSITAT GRAZ · GrazAustria
MRI. TOOLS GMBH · BerlinGermany
OSLOMET - STORBYUNIVERSITETET · OsloNorway
POLITECHNIKA WARSZAWSKA · WarszawaPoland
SCANCO MEDICAL AG · BruettisellenSwitzerland
SYNTELLIX AG · HannoverGermany
UNIVERSITETET I OSLO · OsloNorway

MgSafe · Promoting patient safety by a novel combination of imaging technologies for biodegradable magnesium implants

Results in brief

Promoting patient safety by a novel combination of imaging technologies for biodegradable magnesium implants

Project objective

Participants

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