Treatment of craneofacial syndromes with biodegradable plates, screws and wire

Información del proyecto

Identificador del acuerdo de subvención: BMH4983892

Proyecto cerrado

Fecha de inicio 1 Mayo 1998

Fecha de finalización 31 Enero 2002

Financiado con arreglo a

• Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998

Coste total

Sin datos

Aportación de la UE

Sin datos

Coordinado por

UNIVERSITY OF OULU
Finland

Objetivo

Craniofacial syndromes represent a group of rare and very rare diseases with 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: 1) 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 bioabsorbable materials many-fold, by partner Tampere. Great financial advantage is gained by avoiding a second operation for removal of osteosynthesis material. This will reduce the cost of treatment by about 25%. The use of biodegradable screws diminishes the risk of brain damage. Biodegradable matenals can be used in the skulls of small infants.

There is a strong need for biodegradable osteofixation materials (plates, screws and wires) in craniofacial surgery. These are eliminated via the normal metabolism of the organism. Presently available metallic osteofixation 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 neuroradiological 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 multicentre clinical tests will be carried out to demonstrate that these biodegradable materials are safe to use in cranial bone fixation.

The project coordinator Oulu is responsible for planning the prototypes, and for exponential and clinical testing of the material. A manufacturer, partner Tampere (an SME) is responsible for production of the implant prototypes. The primary users are leading clinics and craniofacial centres in Munich, London, Innsbruck, Gothenburg and Paris. They are responsible for experimental, clinical and multicentre clinical tests of the materials, and follow-up. The small biodegradable osteofixation devices, which 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 precompetitive 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, osteofixation, cranial bones.

Ámbito científico (EuroSciVoc)

• ciencias médicas y de la salud › medicina clínica › cirugía
• ciencias sociales › economía y empresa › gestión y empresas › empleo
• ingeniería y tecnología › biotecnología industrial › biomaterial

Programa(s)

• FP4-BIOMED 2 - Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998

Tema(s)

• 4.6 - RARE DISEASES

Convocatoria de propuestas

Datos no disponibles

Régimen de financiación

CSC - Cost-sharing contracts

Coordinador

UNIVERSITY OF OULU

• Aportación de la UE: Sin datos
• Dirección: 52 A,Kajaanintie 50 ; 90221 OULU ; Finlandia
• Coste total: Sin datos

Participantes (5)

HOPITAL NECKER - ENFANTS MALADES

Francia

• Aportación de la UE: Sin datos
• Dirección: 130,Rue de Sèvre 149 ; 75116 PARIS
• Coste total: Sin datos

LINVATEC BIOMATERIALS OY

Finlandia

• Aportación de la UE: Sin datos
• Dirección: 6 - 8 L,Hermiankatu 6 - 8 L ; 33720 TAMPERE
• Coste total: Sin datos

Leopold-Franzens-Universität Innsbruck

Austria

• Aportación de la UE: Sin datos
• Dirección: 35,Anichstrasse ; 6020 Innsbruck
• Coste total: Sin datos

UNIVERSITY COLLEGE LONDON

Reino Unido

• Aportación de la UE: Sin datos
• Dirección: 30,Guilford Street 30 ; WC1N 1EH LONDON
• Coste total: Sin datos

University of Göteborg

Suecia

• Aportación de la UE: Sin datos
• Dirección: Sahlgrenska Sjukhuset ; 413 45 Göteborg
• Coste total: Sin datos