Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty

Study Overview
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Brief Summary
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Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip. Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center J. Monod of Flers.

Official Title
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Prospective and Observational Study of HYPE SCS Stems

Conditions
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Hip Arthropathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old. Patients covered by health insurance system Patients requiring a total hip arthroplasty, implanted swith a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup Exclusion Criteria: Patient who expressed opposition to participation in the study and to the use of his personal data Patient unable to understand surgeon's instructions and meet follow-ups requirements Patient presenting a contraindication indicated in the IFU of both implantsw Patient presenting a contraindication to have an X-ray Patients implanted with a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup, in context of off-label use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate according to Kaplan-Meier | whatever the cause of revision | per operative period to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | questionnary with a 4 item-scale | per operative period to 5 years | 
| Adverse events | Type and occurence of adverse events | per operative period to 5 years | 
| Functional improvement | This information will be documented through patient questionnary Harris Hip Score | per operative period to 5 years | 
| Functional improvement | This information will be documented through patient questionnary Devane classification | per operative period to 5 years | 
| Pain release | This information will be documented through patient questionnary : Harris Hip Score | per operative period to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Prosthesis