Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

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. Revision risk factors reported when considering the main surgical approaches. Studied from the Dutch arthroplasty registry found a revision rate in hemiarthroplasty (HA) of 1.6% at 1 year and 2.5% at 5 years postoperatively. For total hip replacement (THA), the rate was 2.4% at 1 and 4.3% at 5 years postoperatively. Analyze shows that the risk factors for hemiarthroplasty were male sex, age under 80 (regardless of gender), posterolateral approach and uncemented fixation. The risk factors for HAT were exactly the same, but they found that smoking also played a role. It should be noted that age as a risk factor for revision is not a risk during the first year after the fracture, but becomes one in the years that follow. In order to maintain compliance with the directive on medical devices (93/42 / EEC [M5]) and the future regulation (EU) (2017/745) relating to medical devices, SERF has set up post-market clinical follow-ups ( PMCF). This PMCF study aims to improve knowledge related to the performance, safety and benefit / risk ratio of the Sagitta EVL-R stem and to monitor patient care strategy through this clinical evaluation. Significant clinical results as well as safety must be confirmed with this patient cohort. It is important to note that this cohort reflects the specific care strategy of the University Hospital of Poitiers. Therefore, the strategy could be different between hospitals and countries.

Official Title
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Retro-prospective and Observational Study of 120 Patients for the Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

Conditions
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Hip Arthropathy

Intervention / Treatment
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* Device: Total Hip Arthroplasty Revision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old. Patients that were treated with the sagitta EVL-R stem for an indication of arthroplasty and according to the Instruction For Use (IFU). Primary or secondary arthrosis, Advanced joint destruction resulting from rheumatoid arthritis or traumatic arthritis, A fracture or an avascular necrosis, Following a previous surgical operation, on condition that the new device does not interfere with the material in place. indicated in the case of primary or secondary arthrosis, displaced sub-capital or transcervical fracture as well as stages I and IIB bone loss according to the PAPROWSKI classification. The SAGITTA EVOLUTION for REVISION implant is recommended for indications according to the bone loss classifications of SOFCOT stages I to VI, PAPROSKY types I to VI and the AAOS types Ia to Ic. Dysplasia Exclusion Criteria: Patient presenting a contraindication indicated in the IFU.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Total Hip Arthroplasty Revision|Hip revision surgery is performed to repair an artificial hip joint (prosthesis) that has been damaged over time due to an infection, or due to normal wear and tear of the prosthetic hip. Revision surgery helps to correct the problem so the hip can function normally again.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate according to Kaplan-Meier |  | Between 5 and 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation | Between 5 and 8 years | 
| Functional improvement | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation | Between 5 and 8 years | 
| Pain release | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation | Between 5 and 8 years |