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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.
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.
The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.
Secondary objectives are to :
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| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate at Mid/Long Term Follow-up | Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision | At 7/10 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 7/10 years after surgery |
| Adverse Events |
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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 31/01/2010 and 31/12/2015.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Loire Vendée Océan | Challans | Vendée | 85300 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Per Protocol Population | The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Per Protocol Population | Subjects (number of hips) implanted with SAGITTA EVL-R meeting inclusion and 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/Long Term Follow-up | Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision | Posted | Number | percentage of implant survival | At 7/10 years after surgery | number of implants | number of implants |
|
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per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants.
So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants.
On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
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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 | Subjects (number of hips) implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| femoral fracture due to a fall | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall leading to malleolus fracture | Surgical and medical procedures | Systematic Assessment |
Considering the retrospective aspect of this investigation, some preoperative data are missing or incomplete.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | SERF | +33 4.72.05.60.10 | clinical@serf.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2022 | Jun 18, 2026 | Prot_SAP_000.pdf |
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List type and occurence of adverse events
| At 7/10 years after surgery |
| Oblivion of Prosthesis | Assess the degree of forgetfulness of the prosthesis using FJS-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 7/10 years after surgery |
| Absence of Squeaking | Number of patients experiencing no squeaking | At 7/10 years after surgery |
| Functional Improvement | The only measure to be considered is "Modified Harris Hip Score" which consists of a 0 to 100 points scale (100 points is the better outcome). The data retrieved from site is only 1 figure ranging from 0 to 100. | At 7/10 years after surgery |
| number of implants |
|
| years |
| number of implants |
|
|
| Sex: Female, Male | Count of Units | number of implants | number of implants |
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| Race/Ethnicity, Customized | Count of Units | number of implants | number of implants |
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| Region of Enrollment | Number | number of implant | number of implants |
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| Weight | Missing data in patient charts for 25 hips | Mean | Standard Deviation | kg | number of implants |
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| Size | missing data in patient charts for 20 hips | Mean | Standard Deviation | cm | number of implants |
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| Hip side | Number | number of implants | number of implants |
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| number of implants |
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| 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 | 9 patients (9 implants) of the per protocol population (43 patients / 46 implants) have reached 7/10 years follow-up | Posted | Count of Units | number of implants | At 7/10 years after surgery | number of implants | number of implants |
|
|
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| Secondary | Adverse Events | List type and occurence of adverse events | Posted | Number | number of implants | At 7/10 years after surgery | number of implants | number of implants |
|
|
|
| Secondary | Oblivion of Prosthesis | Assess the degree of forgetfulness of the prosthesis using FJS-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 | Only 9 patients (9 implants) of the per protocol population (43 patients / 46 implants) have reached 7/10 years follow-up | Posted | Mean | Standard Error | score on a scale | At 7/10 years after surgery | number of implants | number of implants |
|
|
|
| Secondary | Absence of Squeaking | Number of patients experiencing no squeaking | Only 9 patients (9 implants) of the per protocol population (43 patients / 46 implants) have reached 7-10 years follow up | Posted | Number | number of implants | At 7/10 years after surgery | number of implants | number of implants |
|
|
|
| Secondary | Functional Improvement | The only measure to be considered is "Modified Harris Hip Score" which consists of a 0 to 100 points scale (100 points is the better outcome). The data retrieved from site is only 1 figure ranging from 0 to 100. | Only 9 patients (9 implants) of the per protocol population (43 patients/46 implants) have reached 7-10 years follow-up | Posted | Mean | Standard Deviation | score on a scale | At 7/10 years after surgery | number of implants | number of implants |
|
|
|
| 23 |
| 43 |
| 15 |
| 46 |
| 8 |
| 46 |
| Revision | Surgical and medical procedures | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Arterial disease of lower limb | Vascular disorders | Systematic Assessment |
|
| Femoropopliteal and fibular recanalization | Vascular disorders | Systematic Assessment |
|
| Fall leading to subtrochanteric fracture | Surgical and medical procedures | Systematic Assessment |
|
| Fall leading to supracondylar fracture | Surgical and medical procedures | Systematic Assessment |
|
| Prosthesis loosening | Surgical and medical procedures | Systematic Assessment |
|
| Replacement of locking screw | Surgical and medical procedures | Systematic Assessment |
|
| Nodular lesion on leg | Surgical and medical procedures | Systematic Assessment |
|
| Ulcerative wounds on leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arterial disease of lower limb | Vascular disorders | Systematic Assessment | Diffuse peripheral arterial disease of the lower limb * |
|
| Fibrinolysis catheter removal | Vascular disorders | Systematic Assessment |
|
| Fall leading to hip trauma | Surgical and medical procedures | Systematic Assessment |
|
| Fall and impairment of general status | General disorders | Systematic Assessment |
|
| Femoral fracture due to a fall | Surgical and medical procedures | Systematic Assessment |
|
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| Rather unsatisfied |
|
| Very unsatisfied |
|
| Title | Measurements |
|---|---|
|
| Infection |
|
| Deep vein thrombosis |
|
| Fall leading to malleolus fracture |
|
| Ulcerative wounds on leg |
|
| Arterial disease of lower limb |
|
| Fibrinolysis catheter removal |
|
| Femoropopliteal and fibular recanalization |
|
| Fall leading to hip trauma |
|
| Fall and impairment of general status |
|
| Fall leading to subtrochanteric fracture |
|
| Fall leading to supracondylar fracture |
|
| Prosthesis loosening |
|
| Replacement of locking screw |
|
| Nodular lesion on leg |
|