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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty

Conditions
-----------------
Hip Arthropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Per operative period to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional improvement | The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation | Per operative period to 10 years | 
| Pain release | The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation | Per operative period to 10 years | 
| Patient satisfaction | The information will be collected from patient through questionnaires to compare preoperatively situtation to last follow-up situtation | Per operative period to 10 years | 
| Adverse event | Type and occurence of adverse events | Per operative period to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Arthroplasty