Authors' objectives: The objectives of this work were to reassess spinal implants so as to: - determine the indications for spinal implants; - assess their actual benefit per indication; - define their place in therapeutic strategy; - characterise the technical specifications which determine the actual benefit, so as to avoid classification mistakes and to clarify which devices are covered by the current generic description; - propose an updated nomenclature based on the form and composition of devices; - estimate their target population; - define the expectations of CNEDiMTS regarding clinical trials needed for inclusion under the brand name on the List of products and services qualifying for reimbursement (LPPR) ; - define the conditions of use and prescription for inclusion of the products on the LPPR. The working method is based on a systematic review of the literature and an analysis of the dossiers submitted by manufacturers, and draws on the expertise of healthcare professionals meeting in the multidisciplinary working group dedicated to the subject.

Authors' recommendations: The CNEDiMTS accepted most of the working group's proposals, adding a few precisions about the benefit of reconstructive vertebral body implants. In fact, after corporectomy the spine is unstable, and reconstruction implants after corporectomy need an effective anchorage system which is provided by a decompression system in the implant. Overall, this assessment has confirmed the benefit of interbody cages, and the distinction of reconstruction implant after corporectomy. In addition, it did not produce any evidence of the benefit of interspinous process spacer or spacer. Two main categories of spinal implants are identified for inclusion under a generic description: 1. interbody cages 2. reconstruction implants after corporectomy The CNEDIMTS defined the criteria for assessing devices under their brand name if they do not meet the technical specifications of the proposed generic descriptions.

Project Status: Completed

Year Published: 2013

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2013-04/rapport_implants_du_rachis_dm_2_vd.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr