Authors' objectives: The objective of this consultation phase is to respond to the comments that were submitted to the CNEDiMTS after the proposed nomenclature was published in the Official Gazette. At the end of the consultation phase, the CNEDiMTS recommendations are sent to CEPS so it can establish the definitive nomenclature and pricing, which will then be published in the Official Gazette.

Authors' recommendations: The CNEDiMTS recommends: - separating out each joint component that is used in a bearing surface and giving it a specific LPPR code; - continuing to include dual mobility cups, highly cross-linked polyethylene acetabular implants and stems with a modular neck under brand name; - creating two generic descriptions for implants made from solid alumina matrix composite ceramic (femoral heads and liners), to be added to the descriptions for implants made from pure solid alumina ceramic; - removing the generic descriptions for monoblock revision stems and revising the generic descriptions for revision stems and reconstruction stems, with the creation of eight generic descriptions based on level of modularity and fixation method; - maintaining the minimum thickness requirement for conventional polyethylene at 8 mm when it is in contact with a metal head (for acetabular components and intermediate cups with an external diameter ≥ 44 mm), while leaving the possibility for reducing the minimum thickness requirement to 6 mm to meet the anatomical constraints of acetabular components and intermediate cups with an external diameter < 44 mm, needed in restricted anatomical situations (i.e. in 5% to 10% of cases); - maintaining the requirement for cemented stems to have a roughness (arithmetic roughness) < 1.26 µm; - extending the indications for hip implants in traumatology to some fractures of the upper extremity of the femur (cervicotrochanteric and trochanteric fractures) where hip arthroplasty may be an alternative to the conventional treatment with osteosynthesis. In addition, the Committee maintains its requirements for the clinical studies needed to support application for inclusion under brand name of a hip implant on the list of products and services qualifying for reimbursement. Where comparative data are necessary, the Committee considers that a randomised controlled trial is the most appropriate tool for evaluation. The Committee points out that it is possible to take the usual practices of each centre into account if randomisation is stratified by centre. In addition, using an independent assessor allows measurement bias to be avoided. The Committee accepts the working group's proposals regarding the clinical trial endpoints expected.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2015-01/rapport_phasecontradictoire_protheseshanche.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