Spinal spacer
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Injection-moulded, functionally graded ceramics for biomedical applications
Contract number
BRE2-CT94-0966 Proposal number
BE-7598-93
Start date
01-Jul-94 Duration
4 years
RTD programme
Brite-EuRam
Coordinator
Dr N Theilgaard

Organisation
Danish Technological Institute

Department Centre for Materials Technology Medical Devices Technology Section
Street
Gregersensvej
City
Taastrup
Country
Denmark Postcode
DK-2630
Telephone
45 43 507230 Fax
45 43 507244
Email
Naseem.Theilgaard@teknologisk.dk
Partner
Biocomposites Ltd., GB
Partner
Morgan Matroc Ltd, Rugby Division, UK
Partner
IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY & MEDICINE, GB
Partner
IRTEC-CNR, I
Partner
FIN-CERAMICA FAENZA srl, I
Summary
The main objective of this study is to design and produce an innovative

spinal spacer which will achieve sound mechanical and biological fusion

between adjacent vertebrae. The spacers will be designed to be

inserted in pairs, one on either side of the space created by disc

excision. They will be located between the vertebral bodies and

designed to interlock with the vertebrae without catching on the dura.

They would be introduced posteriorally by retracting the nerve roots of

the cauda equina, carefully preserving the dura. This demands

production of a complex shape comprising a composite of bioactive

and bioinert materials and will be achieved by the adaptation of injection

moulding technology of technical ceramic materials to produce

components with functionally graded properties. The technology

developed can be thereafter applied to other areas, both in the

biomedical field as well as in the production of technical ceramics.
Project Achievements update April 1999
A new and novel prototype composite spinal spacer has been produced. Extensive in vitro evaluations of the materials of the composite spacer have been carried out. In vivo tests of the materials have been carried out in rabbits. Finite element work was carried out on various designs of spinal spacers. The operative techniques and instrumentation for inserting the spinal spacer have been defined. Materials and manufacturing technologies to produce the proposed device have been identified. In vivo assessment of the prototype has been carried out in a sheep model with very promising results. A patent application has been filed on the device design.


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