Hip Arthropathy
Conditions
Brief summary
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.
Interventions
DEVICETotal 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.
Sponsors
Societe dEtude, de Recherche et de Fabrication
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival Rate of Stems | at 5 years follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | at 5 years follow-up | The information will be collected from the patient by answering a Yes/No question at last follow-up. The following result correspond to the number of patients that have been satisfied |
| Functional Improvement | at 5 years follow-up | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the improvement in 3 scales: improved/unchanged/Worsen. The result present number of patient answering improved. |
| Pain Release | at 5 years follow-up | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the pain diminution with 2 options: Yes or No diminution of pain. Result presents the number of patient having pain diminution |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SAGITTA EVL R Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 46 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | SAGITTA EVL R | — |
|---|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 11.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 64 Participants | — |
| Sex: Female, Male Male | 55 Participants | — |
| Weight | 77.5 Kilograms STANDARD_DEVIATION 20.7 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 46 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Survival Rate of Stems
Time frame: at 5 years follow-up
Population: Patient that have reached the last Follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAGITTA EVL R | Survival Rate of Stems | 94 Percentage of stem unrevised |
Secondary
Functional Improvement
The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the improvement in 3 scales: improved/unchanged/Worsen. The result present number of patient answering improved.
Time frame: at 5 years follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGITTA EVL R | Functional Improvement | 41 Participants |
Secondary
Pain Release
The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the pain diminution with 2 options: Yes or No diminution of pain. Result presents the number of patient having pain diminution
Time frame: at 5 years follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGITTA EVL R | Pain Release | 53 Participants |
Secondary
Patient Satisfaction
The information will be collected from the patient by answering a Yes/No question at last follow-up. The following result correspond to the number of patients that have been satisfied
Time frame: at 5 years follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGITTA EVL R | Patient Satisfaction | 53 Participants |