Foot Diseases
Conditions
Brief summary
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.
Interventions
PROCEDUREOsteosynthesis
Foot pathologies
Sponsors
Societe dEtude, de Recherche et de Fabrication
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject of legal age at the date of implantation; * Subject implanted with one or more implants: FAST Screw, FAST Plate, Toe FAST and VEOFIX Screw between November 2021 and October 2022; * Subject able to understand the information and instructions given by the investigator; * Subject with a social security affiliation.
Exclusion criteria
* Vulnerable persons * People with contraindications (including pregnant women)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the Patient's Pain and Restoration of Walking | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 12 months | 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. |
| Foot Bone Consolidation | 12 months | 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. |
| Patient Satisfaction | 12 months | 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. |
| Adverse Event | Peroperative to 12 months | Type and occurrence of adverse events |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Cohort The description will be carried out on the whole population really included | 124 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant removal | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Total Cohort |
|---|---|
| Age, Continuous | 58.20 years STANDARD_DEVIATION 12.89 |
| Foot position Back of foot | 5 Number of foot |
| Foot position Front + Middle of foot | 3 Number of foot |
| Foot position Front of foot | 123 Number of foot |
| Foot position Middle of foot | 6 Number of foot |
| Height of participant (cm) | 165.85 cm STANDARD_DEVIATION 7.23 |
| Operated foot side Left | 72 Number of foot |
| Operated foot side Right | 65 Number of foot |
| Race/Ethnicity, Customized French nationality | 124 Participants |
| Sex: Female, Male Female | 99 Participants |
| Sex: Female, Male Male | 25 Participants |
| Weight (kg) | 66.72 Kg STANDARD_DEVIATION 14.12 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 121 |
| other Total, other adverse events | 16 / 121 |
| serious Total, serious adverse events | 5 / 121 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Cohort | Reduction of the Patient's Pain and Restoration of Walking | Preoperatively | 42.46 points | Standard Deviation 15.25 |
| Total Cohort | Reduction of the Patient's Pain and Restoration of Walking | 12 months | 88.44 points | Standard Deviation 13.5 |
Secondary
Adverse Event
Type and occurrence of adverse events
Time frame: Peroperative to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Cohort | Adverse Event | Discomfort | 8 Number of foot |
| Total Cohort | Adverse Event | Pain | 3 Number of foot |
| Total Cohort | Adverse Event | Pseudoarthrosis | 2 Number of foot |
| Total Cohort | Adverse Event | Screw protrusion | 2 Number of foot |
| Total Cohort | Adverse Event | Persistent pain (consolidation with screw protrusion) | 1 Number of foot |
| Total Cohort | Adverse Event | Post-operative neurological disorders | 1 Number of foot |
| Total Cohort | Adverse Event | Stiff joint (hallux positioning problem) | 1 Number of foot |
| Total Cohort | Adverse Event | Loss of correction | 1 Number of foot |
| Total Cohort | Adverse Event | Scar disunion (poor effectiveness of meching) | 1 Number of foot |
| Total Cohort | Adverse Event | Locking default between locking screws/plate | 1 Number of foot |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Cohort | Foot Bone Consolidation | Total | 124 Number of foot |
| Total Cohort | Foot Bone Consolidation | Partial | 2 Number of foot |
| Total Cohort | Foot Bone Consolidation | No consolidation | 1 Number of foot |
| Total Cohort | Foot Bone Consolidation | Not determined | 7 Number of foot |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Cohort | Patient Satisfaction | Very satisfied | 103 Number of foot |
| Total Cohort | Patient Satisfaction | Satisfied | 20 Number of foot |
| Total Cohort | Patient Satisfaction | Neither satisfied nor unsatisfied | 6 Number of foot |
| Total Cohort | Patient Satisfaction | Unsatisfied | 5 Number of foot |
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Cohort | Survival Rate | 89.3 percentage of implant survivorship |