PP96 Which Data For Dual Mobility Cups In Hip Arthroplasty?

Abstract

Introduction:The dual mobility concept was invented to prevent postoperative hip dislocation. It has been used for 40 years, but demonstrative data are limited and many designs are available. In France, many implants for hip arthroplasty are reimbursed by the national health insurance system through a generic description that corresponds to a class of products having the same indications and technical features (designs, coatings, types and systems of fixation). Dual mobility cups were one of them until 2017. The ministry decided to set up the assessment of each design of dual mobility cup, marketed in France for their reimbursement.Methods:Manufacturers of these devices submitted medico-technical application dossiers, with technical characteristics and clinical data, to the French National Authority for Health (HAS). HAS has assessed prospectively the actual benefit of these implants.Results:Sixteen companies marketing 42 kinds of dual mobility cups associated with 22, 28 or 32 mm femoral heads and cementless or cemented fixations have submitted dossiers. Their demands were argued on non-specific and specific clinical data. For few implants with non-specific clinical data, arguments to demonstrate the equivalence towards other implants were not accepted for reimbursement. For other implants, the specific data available were only low quality studies. No randomized controlled trials were identified. When the risk/benefit balance was acceptable, the implants were approved for reimbursement and HAS required post-launch data to assess the real-world safety of these implants (i.e. dislocation and long-term survival).Conclusions:All the dual mobility cups marketed in France have been assessed by the French health technology assessment authority. Most of them have been approved for reimbursement, despite of low level of evidence. The brand name inscription enables a specific follow up and the analysis of a post-approval study results in five years.