Craniofacial syndromes represent a group of rare and very rare diseases with a prevalence of 9 to 16 births per million. At present surgically corrected cranial bones are fixed in a new position by using metallic plates, screws and wire. The present project introduces new technology for the fixation of corrected cranial bones,
I) in children with rapidly biodegrading fixation materials and
2) in adults with slower biodegrading fixation materials.
A European dimension is required to obtain reliable information as regards this treatment. Because of the limited number of craniofacial syndromes, information from different centres has to be pooled. A project of this size can only be carried out at a European level. No single country could expect to have experts in all the fields involved.

The project will benefit from the long-standing European expertise in the development of biodegradable materials for surgical use. Of particular importance are the patents regarding increasing the strength of bio-absorbable materials many-fold, by partner Tampere. Great financial advantage is gained by avoiding a second operation for removal of osteo-synthesis material. This will reduce the cost of treatment by about 25 %. The use of biodegradable screws diminishes the risk of brain damage. Biodegradable materials can be used in the skulls of small infants. There is a strong need for biodegradable osteo-fixation materials (plates, screws and wires) in craniofacial surgery. These are eliminated via the normal metabolism of the organism. Presently available metallic osteo-fixation devices have been found to migrate to the inside of the skull. There may be a danger of brain damage. Metallic plates and screws inhibit skull growth and interfere with neuro-radiological investigations; they usually have to be removed in another operation. Biodegradable materials may solve these problems. This demonstration project aims to overcome the barriers to exploitation of this new technology.

The claimed innovative aspect of the project is to demonstrate the suitability of this new method of treatment, the objectives of which are:
1) new prototypes for biodegradable mini-screws (diameter 2 mm),
2) new prototypes of biodegradable plates and
3) biodegradable wire will be produced.
4) These will be tested experimentally and
5) pilot clinical tests and multi-centre clinical tests will be carried out to demonstrate that these biodegradable materials are safe to use in cranial bone fixation.

The project co-ordinator Oulu (1) is responsible for planning the prototypes, and for experimental and clinical testing of the material. A manufacturer, partner Tampere (2, an SME) is responsible for production of the implant prototypes. The primary users are leading clinics and craniofacial centres in Munich (3), London (4), Innsbruck (5), Gothenburg (6) and Paris (7). They are responsible for experimental, clinical and multi-centre clinical tests of the materials, and follow-up. The small biodegradable osteo-fixation devices that will be developed for craniofacial surgery are future profitable products with many potential users. The project will contribute to the improvement of health care in Europe. It will strengthen the competitiveness of the European health industry working in this field as well as increase employment. EU funding is needed to match strong competitors from the USA and Japan. This demonstration project will prove the technical viability of this new technology and its possible economic advantages. It is pre-competitive and focuses on a new application of biodegradable materials. Participation involves both producers and users. The project combines scientific basic knowledge and results of clinical testing of biodegradable materials as regards the treatment of rare craniofacial syndromes.

This is a shared-cost DEMONSTRATION PROJECT, the areas covered in the BIOMED programme being 8.2 and 4.6. Craniofacial surgery, craniofacial syndromes, biomaterials, biodegradable materials, polylactide, polyglycolide, osteo-fixation, cranial bones. Keywords: craniofacial surgery, craniofacial syndromes, biomaterials, biodegradable materials, polyactide, polyglycolide, osteo-fixation, cranial bones