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This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative.
The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.
The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.
The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosynthesis | Procedure | Foot pathologies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the Patient's Pain and Restoration of Walking | The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows : Between 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | Determination of the Kaplan-Meier type survival curve, with any revision as the endpoint whatever the cause. At each inflection point, a revision surgery with removal or revision surgery with removal or change of a component of the implant under consideration All causes of revision are considered. Patients who have died or been lost to follow-up will be included in the analysis. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Men or women of legal age, for whom one of the devices is implanted according to the instructions for use. These patients will be monitored according to standard care. As the series is observational and has an additional procedure that is neither burdensome nor invasive, all implanted patients will be considered.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Saint-Martin | Pessac | 33600 | France |
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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 | Reduction of the Patient's Pain and Restoration of Walking | The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows : Between 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. | Posted | Mean | Standard Deviation | points | 12 months |
|
12 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 adverse event occurred in an implanted foot. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent pain (consolidation with screw protrusion) | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent / residual pain | Injury, poisoning and procedural complications | Systematic Assessment |
This investigation had planned to collect 320 patients (40 per surgeon). However, the amount of data collected for FAST plates (and associated screws), VEOFIX screws and Toe FAST is limited due to a lack of inclusion or an overestimation of the capacity of the investigation.
| 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 | Nov 10, 2022 | Aug 9, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D001174 | Arthrodesis |
| D010027 | Osteotomy |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Foot Bone Consolidation | The information will be collected through investigator's question : "on radiographic reading, is the foot bone consolidation satisfactory? : 4 answers are proposed: "total / partial / null / no information". | 12 months |
| Patient Satisfaction | The information will be collected through patient's question : "Considering your expectations, are you satisfied with your operation?" 4 answers are proposed: "I am completely satisfied with the results of my operation results of my operation / My condition has not improved as much as I had hoped, but I but I would be willing to have the same operation for the same result / The operation improved my condition, but I would not be prepared to have the same operation for the same result / My condition is the same or worse than before my operation than before my operation". | 12 months |
| Adverse Event | Type and occurrence of adverse events | Peroperative to 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Operated foot side | Number | Number of foot |
|
| Foot position | Number | Number of foot |
|
| Weight (kg) | Mean | Standard Deviation | Kg |
|
| Height of participant (cm) | Mean | Standard Deviation | cm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Survival Rate | Determination of the Kaplan-Meier type survival curve, with any revision as the endpoint whatever the cause. At each inflection point, a revision surgery with removal or revision surgery with removal or change of a component of the implant under consideration All causes of revision are considered. Patients who have died or been lost to follow-up will be included in the analysis. | Posted | Number | percentage of implant survivorship | 12 months |
|
|
|
| Secondary | Foot Bone Consolidation | The information will be collected through investigator's question : "on radiographic reading, is the foot bone consolidation satisfactory? : 4 answers are proposed: "total / partial / null / no information". | Posted | Number | Number of foot | 12 months |
|
|
|
| Secondary | Patient Satisfaction | The information will be collected through patient's question : "Considering your expectations, are you satisfied with your operation?" 4 answers are proposed: "I am completely satisfied with the results of my operation results of my operation / My condition has not improved as much as I had hoped, but I but I would be willing to have the same operation for the same result / The operation improved my condition, but I would not be prepared to have the same operation for the same result / My condition is the same or worse than before my operation than before my operation". | Posted | Number | Number of foot | 12 months |
|
|
|
| Secondary | Adverse Event | Type and occurrence of adverse events | Posted | Number | Number of foot | Peroperative to 12 months |
|
|
|
| 121 |
| 5 |
| 121 |
| 16 |
| 121 |
| Arthrodesis pseudarthrosis | Surgical and medical procedures | Systematic Assessment |
|
| Post-operative neurological disorders | Nervous system disorders | Systematic Assessment |
|
| Screw protrusion | Surgical and medical procedures | Systematic Assessment |
|
| Pseudarthrosis | Surgical and medical procedures | Systematic Assessment |
|
| Screws protrusion | Surgical and medical procedures | Systematic Assessment |
|
| Discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Loss of correction | Surgical and medical procedures | Systematic Assessment |
|
| Scar disunion (poor effectiveness of meching) | Surgical and medical procedures | Systematic Assessment |
|
| Locking default between locking screws /plate | Surgical and medical procedures | Systematic Assessment |
|
| Stiff joint (hallux positioning problem) | Surgical and medical procedures | Systematic Assessment |
|
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| Not determined |
|
| Title | Measurements |
|---|---|
|
| Unsatisfied |
|