Doctor: Laëtitia Rodrigues

Title: Evaluating the performance of a femoral osteosynthesis implantable medical device for hip fracture prevention

Supervisor: Sylvie Chevret

Doctoral school: ED 393 Epidemiology and Biomedical Information Sciences, Université Paris Cité

Date of thesis defense: 11/2020

Jury: Éric Vicaut, Alain Bernard, David Orlikowski, Marlène Durand, François Cornélis, Mahmoud Zureik

Thesis summary:

Hip fracture is a major public health issue in our modern society, increasing with the years due to the increase of the population and its aging. Indeed, in older people, hip fracture occurs mainly after a low energy trauma equal to a fall from its height and often linked to a bone fragility (osteoporosis). It can also occur in cancer patients presenting secondary lesions at bone level (bone metastases). Literature reports really few solutions already existing for surgical prevention of hip fractures due to bone aging. Indeed, the main treatment prescribed is the antiosteoporosis drug, with additional vitamin D, calcium or any other complement to slow bone degradation. As well, in cancer patients, a treatment with drugs or radiotherapy is often prescribed, simultaneously to a treatment by hormonotherapy or chemotherapy. Several medical devices combined with bone cement are developed in this indication, but their level of evidence stay limited. This thesis work had for main objective to evaluate the clinical efficacy of an innovative medical device for the prevention of hip fracture either due to osteoporosis or bone metastases. Firstly, we did a literature review on both problematics of this thesis, namely the prevention of hip fracture and the evaluation of the efficacy of an innovative and implantable medical device, and in particular the one studied here (Y-STRUT®, Hyprevention, Pessac, France). Secondly, we have elaborated an on-line survey of experts’ belief, as well as a state of the art on methods used in surgery for the prevention of hip fracture. The development and set-up of observational studies have also been done so as to collect new clinical data. Synthesis of all these results has then be discussed in order to conclude on the clinical efficacy of the studied innovative medical device.

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