Universität zu Köln

Oikonomidis, Stavros ORCID: 0000-0002-7637-8611, Sobottke, Rolf, Wilke, Hans-Joachim ORCID: 0000-0001-6007-8844, Herren, Christian, Beckmann, Agnes, Zarghooni, Kourosh and Siewe, Jan (2019). Material failure in dynamic spine implants: are the standardized implant tests before market launch sufficient? Eur. Spine J., 28 (4). S. 872 - 883. NEW YORK: SPRINGER. ISSN 1432-0932

Full text not available from this repository.

Abstract

PurposeInternational Standards Organization (ISO) 12189 and American Society for Testing and Materials F2624 are two standard material specification and test methods for spinal implant devices. The aim of this study was to assess whether the existing and required tests before market launch are sufficient.MethodsIn three prospective studies, patients were treated due to degenerative disease of the lumbar spine or spondylolisthesis with lumbar interbody fusion and dynamic stabilization of the cranial adjacent level. The CD HORIZON BalanC rod and S-4 Dynamic rod were implanted in 45 and 11 patients, respectively.ResultsA fatigue fracture of the material of the topping off system has been found in five cases (11%) for the group fitted with the CD HORIZON BalanC rod. In the group using the S-4 Dynamic rod group, a material failure of the dynamic part was demonstrated in seven patients (64%). All three studies were interrupted due to these results, and a report to the Federal Institute for Drugs and Medical Devices was generated.ConclusionSpinal implants have to be checked by a notified body before market launch. The notified body verifies whether the implants fulfil the requirements of the current standards. These declared studies suggest that the current standards for the testing of load bearing capacity and stand ability of dynamic spine implants might be insufficient. Revised standards depicting sufficient deformation and load pattern have to be developed and counted as a requirement for the market launch of an implant. [GRAPHICS]

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Oikonomidis, Stavros UNSPECIFIED orcid.org/0000-0002-7637-8611 UNSPECIFIED Sobottke, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Wilke, Hans-Joachim UNSPECIFIED orcid.org/0000-0001-6007-8844 UNSPECIFIED Herren, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Beckmann, Agnes UNSPECIFIED UNSPECIFIED UNSPECIFIED Zarghooni, Kourosh UNSPECIFIED UNSPECIFIED UNSPECIFIED Siewe, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-152255
DOI:	10.1007/s00586-019-05880-y
Journal or Publication Title:	Eur. Spine J.
Volume:	28
Number:	4
Page Range:	S. 872 - 883
Date:	2019
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1432-0932
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ADJACENT SEGMENT DEGENERATION; TERM-FOLLOW-UP; LUMBAR SPINE; PRECLINICAL EVALUATION; CONTROLLED-TRIAL; IN-VIVO; FUSION; STABILIZATION; INSTRUMENTATION; DISEASE Multiple languages Clinical Neurology; Orthopedics Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15225