Hallux ValgusNCT05523219
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
An observational study of Hallux Valgus, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2021to 7 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 Practice"undirectly 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).
- Conditions
- Hallux Valgus
- Medical subject headings
- Hallux Valgus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 12 months
Secondary outcomes (2)
Patient Satisfaction
The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation
Measured: 3 and 12 months
Number of Complications Observed During the Clinical Investigation
Number of complications observed throughout the clinical investigation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Feb 2021
- Primary completion2 Mar 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe dEtude, de Recherche et de Fabrication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523219
- Sponsor's protocol ID
- Veofix varisation staples
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2022
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
- ClinicalTrials.gov ID
- NCT05523219
- Acronym / sponsor ID
- Veofix varisation staples
- Conditions
- Hallux Valgus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Practice"undirectly 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AOFAS Score
Time frame: 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.
2 secondary outcomes
Patient Satisfaction
Time frame: 3 and 12 months
Number of Complications Observed During the Clinical Investigation
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS Score (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.