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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival rate according to Kaplan-Meier | whatever the cause of revision | per operative period to 5 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Recruitment of adults patients representing 120 hips operated between 2020 and 2022 (8 patients have been implanted at both hips).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier " J. Monod ", | Flers-en-Escrebieux | 61104 | France |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2026 | |
| Reset | Jun 3, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 3, 2026 | |||
| Jun 24, 2026 |
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| 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 |