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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty Revision | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate of Stems | at 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 5 years follow-up |
| Functional Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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Recruitment 120 adults patients representing 124 hips operated between 2011 and 2014.
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| Name | Affiliation | Role |
|---|---|---|
| Louis-Etienne GAYET, MD | Poitiers University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Poitiers | Poitiers | 86000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19345630 | Background | Delaunay C, Epinette JA, Dawson J, Murray D, Jolles BM. Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population. Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. doi: 10.1016/j.otsr.2009.01.003. Epub 2009 Apr 3. | |
| 21435964 | Background | Girard J, Roche O, Wavreille G, Canovas F, Le Beguec P. Stem subsidence after total hip revision: 183 cases at 5.9 years follow-up. Orthop Traumatol Surg Res. 2011 Apr;97(2):121-6. doi: 10.1016/j.otsr.2010.10.006. Epub 2011 Mar 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAGITTA EVL R | Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SAGITTA EVL R | Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival Rate of Stems | Patient that have reached the last Follow-up. | Posted | Number | Percentage of stem unrevised | at 5 years follow-up | Stems implanted | Stems implanted |
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At 5 years follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAGITTA EVL R | Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Louis Etienne GAYET | CHU de Poitiers | +33(0)5.49.44.44.92 | Louis-Etienne.GAYET@chu-poitiers.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2019 | May 3, 2024 | Prot_000.pdf |
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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. |
| at 5 years follow-up |
| 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 | at 5 years follow-up |
| 26333733 | Background | Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141. |
| 30080985 | Background | Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6. |
| 25701193 | Background | Tangsataporn S, Safir OA, Vincent AD, Abdelbary H, Gross AE, Kuzyk PR. Risk Factors for Subsidence of a Modular Tapered Femoral Stem Used for Revision Total Hip Arthroplasty. J Arthroplasty. 2015 Jun;30(6):1030-4. doi: 10.1016/j.arth.2015.01.009. Epub 2015 Jan 21. |
| years |
|
| Sex: Female, Male | Sex information were not collected for one subject | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Stems implanted |
|
|
| 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 | Posted | Count of Participants | Participants | at 5 years follow-up |
|
|
|
| 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. | Posted | Count of Participants | Participants | at 5 years follow-up |
|
|
|
| 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 | Posted | Count of Participants | Participants | at 5 years follow-up |
|
|
|
| 46 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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