Hallux Valgus
Conditions
Brief summary
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows: * To assess functional clinical score's evolution, * To evaluate patient's satisfaction * To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021. 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: * Standard ISO 14155:2020 Good Clinical Practiceundirectly applicable; * Regulation (UE) 2016/679 (RGPD) ; * Regulation (UE) 2017/745 (MDR) ; * MEDDEV 2.12.1; * Local regulation (loi jardé , loi informatique et libertés ). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).
Interventions
None listed
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
* Man or woman * Major patient on the date of surgery * Patient with foot pathology requiring Akin osteotomy * Patient not opposed to the collection of data
Exclusion criteria
* Patient unable to understand and follow the postoperative instructions * Patient with a contraindication to the use of the implant * Non-implanted patient with a varisation staple
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS Score | 3 and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 3 and 12 months | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation |
| Number of Complications Observed During the Clinical Investigation | 12 months | Number of complications observed throughout the clinical investigation |
Countries
France
Participant flow
Recruitment details
Patients implanted with VEOFIX varisation staples between 15/02/2021 and 15/05/2021 in Clinique Victor Hugo.
Pre-assignment details
No SERF assembly
Participants by arm
| Arm | Count |
|---|---|
| Total Cohort The description will be carried out on the whole population really included | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Wrong inclusion | 1 |
Baseline characteristics
| Characteristic | Total Cohort |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 14.5 |
| Indication : Hallux Valgus | 80 Participants |
| Race/Ethnicity, Customized French nationality | 80 Participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 14 Participants |
| Side : Right, Left Left | 29 Participants |
| Side : Right, Left Right | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 7 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
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.
Time frame: 3 and 12 months
Population: The number of scores is different for each follow-up. In fact, this score is recovered during patient follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Cohort | AOFAS Score | Preoperatively | 41.2 points | Standard Deviation 17.5 |
| Total Cohort | AOFAS Score | 3 months | 77.0 points | Standard Deviation 9.1 |
| Total Cohort | AOFAS Score | 12 months | 88.1 points | Standard Deviation 9.4 |
Secondary
Number of Complications Observed During the Clinical Investigation
Number of complications observed throughout the clinical investigation
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Cohort | Number of Complications Observed During the Clinical Investigation | Neurogenic pain after loco-regional anaesthesia | 4 events |
| Total Cohort | Number of Complications Observed During the Clinical Investigation | Paraesthesia O1 | 1 events |
| Total Cohort | Number of Complications Observed During the Clinical Investigation | Hallux varus | 2 events |
Secondary
Patient Satisfaction
The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation
Time frame: 3 and 12 months
Population: * 80 patients preoperatively;~* 78 patients were available at 3 months follow-up.~* 73 patients were available at 12 months follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Total Cohort | Patient Satisfaction | 3 months | Very satisfied | 17 Participants |
| Total Cohort | Patient Satisfaction | 3 months | Satisfied | 56 Participants |
| Total Cohort | Patient Satisfaction | 3 months | Dissatisfied | 5 Participants |
| Total Cohort | Patient Satisfaction | 3 months | Dissappointed | 0 Participants |
| Total Cohort | Patient Satisfaction | 12 months | Very satisfied | 43 Participants |
| Total Cohort | Patient Satisfaction | 12 months | Satisfied | 28 Participants |
| Total Cohort | Patient Satisfaction | 12 months | Dissatisfied | 1 Participants |
| Total Cohort | Patient Satisfaction | 12 months | Dissappointed | 1 Participants |