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This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows:
Patients were implanted and followed as per standard of care led in the investigational site.
The following regulation and guidelines were followed for this investigation:
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| Measure | Description | Time Frame |
|---|---|---|
| AOFAS Score | To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator. The scores range from 0 to 100, The average preoperative score was 50 to 60 points. Post-operatively, a score of 80 points is a good post-operative result, with the patient experiencing no or low levels of residual pain and full or partial recovery of joint function. The AOFAS Score is considered excellent between 90 and 100 points, good between 80 and 89, fair between 60 and 79, and poor below 60 points. | 3 and 12 months |
| 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 | 3 and 12 months |
| Number of Complications Observed During the Clinical Investigation |
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Inclusion Criteria:
Exclusion Criteria:
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Due to its non-comparative design, no patient was randomized. Every patient who respected the selection criteria were included to create an exhaustive and consecutive cohort
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victor Hugo Clinical | Paris | Île-de-France Region | 75 | France |
No SERF assembly
Patients implanted with VEOFIX varisation staples between 15/02/2021 and 15/05/2021 in Clinique Victor Hugo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Cohort | The description will be carried out on the whole population really included |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Cohort | The description will be carried out on the whole population really included |
| 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 | AOFAS Score | To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator. The scores range from 0 to 100, The average preoperative score was 50 to 60 points. Post-operatively, a score of 80 points is a good post-operative result, with the patient experiencing no or low levels of residual pain and full or partial recovery of joint function. The AOFAS Score is considered excellent between 90 and 100 points, good between 80 and 89, fair between 60 and 79, and poor below 60 points. | The number of scores is different for each follow-up. In fact, this score is recovered during patient follow-up. | Posted | Mean | Standard Deviation | points | 3 and 12 months |
|
14.9 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 | Total Cohort | The description will be carried out on the whole population really included |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurogenic pain after locoregional anaesthesia | Nervous system disorders | Systematic Assessment |
The 12 months follow-up was done in consultation, but when the patient could not move, it was done by telephone.
There is a delay in follow-ups for 12 months due to school holidays.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | SERF | +33 4.72.05.60.10 | 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 17, 2020 | Dec 9, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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Number of complications observed throughout the clinical investigation |
| 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Side : Right, Left | Count of Participants | Participants |
|
| Indication : Hallux Valgus | Count of Participants | Participants |
|
|
|
| Secondary | Patient Satisfaction | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation |
| Posted | Count of Participants | Participants | 3 and 12 months |
|
|
|
| Secondary | Number of Complications Observed During the Clinical Investigation | Number of complications observed throughout the clinical investigation | Posted | Number | events | 12 months |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 7 |
| 80 |
| Paresthesia O1 | Surgical and medical procedures | Systematic Assessment |
|
| Hallux Varus | Surgical and medical procedures | Systematic Assessment |
|
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| Dissatisfied |
|
| Dissappointed |
|
| 12 months |
|
|
|