Foot DiseasesNCT05672069

Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices

An observational study of Foot Diseases, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Foot Diseases
What is being tested?: Osteosynthesis
Type of treatment: Surgery or procedure
How many people: 124 participants
Where: 1 siteFrance
Study dates: 7 Dec 2022to 13 Dec 2023
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: 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.

Who may be able to join

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.

Who cannot join

Vulnerable persons
People with contraindications (including pregnant women)

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpital Privé Saint-Martin
Pessac, 33600

Other trials in France

About this study

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.

Conditions: Foot Diseases
Being tested: Osteosynthesis
Medical subject headings: Foot Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OsteosynthesisProcedure or surgery
Also called Arthrodesis, Osteotomy
Foot pathologies

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (4)

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.
Measured: 12 months
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".
Measured: 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".
Measured: 12 months
Adverse Event
Type and occurrence of adverse events
Measured: Peroperative to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202213 Dec 2023

First posted5 Jan 2023
Study start7 Dec 2022
Primary completion13 Dec 2023
Study completion13 Dec 2023

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 Foot DiseasesStudies 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: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05672069
Sponsor's protocol ID: 2021-08
Status last verified: Apr 2024
First submitted: 3 Jan 2023
Last updated: 13 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Foot Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
ClinicalTrials.gov ID: NCT05672069
Acronym / sponsor ID: 2021-08
Conditions: Foot Diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
Study start: 7 Dec 2022 (actual)
Primary completion: 13 Dec 2023 (actual)
Study completion: 13 Dec 2023 (actual)
First posted: 5 Jan 2023 (actual)
Results: Posted 13 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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: 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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

Vulnerable persons
People with contraindications (including pregnant women)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OsteosynthesisAlso: Arthrodesis, OsteotomyFoot pathologies	Procedure or surgery	–

Primary outcome

Reduction of the Patient's Pain and Restoration of Walking
Time frame: 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.

4 secondary outcomes

Survival Rate
Time frame: 12 months
Foot Bone Consolidation
Time frame: 12 months
Patient Satisfaction
Time frame: 12 months
Adverse Event
Time frame: Peroperative to 12 months

Results and safety

Results posted to the registry on 13 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Cohort	124	121

Primary outcome: Reduction of the Patient's Pain and Restoration of Walking

Time frame: 12 months. Mean (Standard Deviation). Unit: points

Measure	Total Cohort n = 121
Preoperatively	42.46 (15.25)
12 months	88.44 (13.50)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Cohort	5 of 121 (4.1%)	16 of 121 (13.2%)	0 of 121

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Foot Diseases

RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
Active, not recruitingPhase 4
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
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Not yet recruiting
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Diabetic Foot Ulcer

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 Foot Diseases, 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 2 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 13 Jan 2025. 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 13 Jan 2025). 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?

Reduction of the Patient's Pain and Restoration of Walking (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672069.

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 13 Jan 2025.