Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

N/AActive Not RecruitingNCT05524350

Societe dEtude, de Recherche et de Fabrication180 enrolled

Overview

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Hip Arthropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female * Degenerative or inflammatory hip disease requiring total hip replacement * Primary or secondary osteoarthritis, * Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin, * Avascular fracture or necrosis, * Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects. * Joint destruction of traumatic origin * Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty). Exclusion Criteria: * Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up * Known pregnancy in progress * Breastfeeding * Patient requiring a bone graft * Neurological disorders or other pathology that may influence locomotion * History of sepsis in the hip to be operated on * Short-term vital prognosis

Outcomes

Primary Outcomes

Survival rate

Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment.