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This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.
This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate at Mid Term Follow-up | Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation. | Between 4 to 7 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice | From per operative period to 4/6 years after surgery |
| Survival Rates at Mid Term Follow-up (by Component) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2016 and 31/12/2018.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Rouen - Hôpital Charles Nicolle | Rouen | Seine Maritime | 76000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Per Protocol Population | All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria. All patients are included in the same arm. No randomization, no control arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Per Protocol Population | All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria |
| 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 at Mid Term Follow-up | Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation. | Posted | Number | percentage of implant survival | Between 4 to 7 years after surgery | number of implants | number of implants |
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|
Until >4-years follow up (maximum duration of 90 months)
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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 | Per Protocol Population | All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Greater trochanter fracture | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | SERF | 0472056010 | clinical@serf.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2022 | Jun 2, 2025 | Prot_000.pdf |
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Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis |
| At 4/6 years after surgery |
| Survival Rates at Mid Term Follow-up (by Etiology) | Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology. Percentage of patients with implant in place dispatched following reason for implantation | At 4/6 years after surgery |
| Patient's Satisfaction | Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied | At 4/6 years after surgery |
| Oblivion of Prosthesis | Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) : FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities | At 4/6 years after surgery |
| Functional Improvement | Evaluate pain, walking, limping and activities of daily life using Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome) | At 4/6 years after surgery |
| number of implants |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Weight | Weight not available for 3 patients (3 hips) | Mean | Standard Deviation | kg | Participants |
|
|
|
| number of implants |
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| Secondary | Adverse Events | List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice | Posted | Number | participants | From per operative period to 4/6 years after surgery | hips implanted | hips implanted |
|
|
|
| Secondary | Survival Rates at Mid Term Follow-up (by Component) | Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis | Posted | Number | percentage of implant survival | At 4/6 years after surgery | number of hips | number of hips |
|
|
|
| Secondary | Survival Rates at Mid Term Follow-up (by Etiology) | Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology. Percentage of patients with implant in place dispatched following reason for implantation | Posted | Number | percentage of implant | At 4/6 years after surgery | hips implanted | hips implanted |
|
|
|
| Secondary | Patient's Satisfaction | Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied | Posted | Number | number of hips | At 4/6 years after surgery | hips implanted | hips implanted |
|
|
|
| Secondary | Oblivion of Prosthesis | Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) : FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities | Posted | Mean | Standard Error | score on a scale | At 4/6 years after surgery | hips implanted | hips implanted |
|
|
|
| Secondary | Functional Improvement | Evaluate pain, walking, limping and activities of daily life using Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome) | Posted | Mean | Standard Deviation | score on a scale | At 4/6 years after surgery | hips implanted | hips implanted |
|
|
|
| 30 |
| 42 |
| 4 |
| 42 |
| 1 |
| 42 |
| Posterior dislocation | Surgical and medical procedures | Systematic Assessment |
|
| Femoral fracture | Surgical and medical procedures | Systematic Assessment |
|
| Fracture with greater trochanter displacement | Surgical and medical procedures | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Femoral fracture |
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| Fracture with greater trochanter displacement |
|
| Title | Measurements |
|---|---|
|
| Rather unsatisfied |
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| Very unsatisfied |
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