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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The expected number of patients in the registry is estimated at 180 patients.The implantation of the total hip prosthesis will be carried out in patients with a hip pathology, in first intention or during a total prosthesis revision. The implant placement will be performed on a continuous series of patients by the investigator according to the eligibility criteria. Post-operative follow-up will be carried out for ten days following the operation, in the hospital concerned. Successive clinical and radiological evaluations will be performed at a date set by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital Center | Rouen | 76000 | France |
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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 |