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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Survival rate — Per operative period to 10 years 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.
Trial sites (1)
Facility
City
Region
Status
Rouen University Hospital Center
Rouen
France
More Societe dEtude, de Recherche et de Fabrication trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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