Hallux DeformityARTHRODESENCT05691075
Metatarsophalangeal Arthrodesis of the Hallux
An observational study of Hallux Deformity, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Deformity
- What is being tested?
- Arthrodesis of the metatarsophalangeal joint
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2023to 16 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw.
Who may be able to join
- Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
- Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
- Patient able to understand information related to the study and complete quality of life questionnaires;
- Patient accepting study follow-up visits;
- Patient having been informed and agreeing to participate in the study.
Who cannot join
- Pregnant or breastfeeding women;
- Patient undergoing lateral ray surgery;
- Patient undergoing revision arthrodesis;
- Patient with a loss of bone substance requiring a graft;
- Patient suffering from chronic inflammatory disease;
- Patient treated with long-term immunosuppressive or corticosteroid treatments;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metatarsophalangeal Arthrodesis of the Hallux : Observational Study Evaluating the Efficacy and Tolerance of Synthetic Methods Using Dorsal Plate and Large-diameter Screws
The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.
Read the detailed description
The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw.
Patients will be divided into two groups:
- patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
- patient undergoing arthrodesis of the hallux by plate (group B)
This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.
- Conditions
- Hallux Deformity
- Being tested
- Arthrodesis of the metatarsophalangeal joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrodesis of the metatarsophalangeal jointProcedure or surgery
Isolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach
| Study group | Role | What they receive |
|---|---|---|
| Metatarsophalangeal arthrodesis of the hallux with large diameter screws | Patient who can benefit from first-line arthrodesis using large-diameter screws Receives: Procedure: Arthrodesis of the metatarsophalangeal joint | |
| Metatarsophalangeal arthrodesis of the hallux by plate | Patient who can benefit from a first intention arthrodesis by dorsal plate Receives: Procedure: Arthrodesis of the metatarsophalangeal joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)
Rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation, obtained with different types of osteosynthesis material: dorsal plate and large-diameter compressive screw
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start15 Mar 2023
- Primary completion16 Jul 2023
- Study completion16 Jul 2023
Why it stopped: only 3 patients were included in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux DeformityStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691075
- Sponsor's protocol ID
- 2022-A02518-35
- Acronym
- ARTHRODESE
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metatarsophalangeal Arthrodesis of the Hallux : Observational Study Evaluating the Efficacy and Tolerance of Synthetic Methods Using Dorsal Plate and Large-diameter Screws
- ClinicalTrials.gov ID
- NCT05691075
- Acronym / sponsor ID
- ARTHRODESE / 2022-A02518-35
- Conditions
- Hallux Deformity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: only 3 patients were included in this study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 16 Jul 2023 (actual)
- Study completion
- 16 Jul 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.
Detailed description
The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw.
Patients will be divided into two groups:
- patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
- patient undergoing arthrodesis of the hallux by plate (group B)
This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metatarsophalangeal arthrodesis of the hallux with large diameter screws | – | Procedure: Arthrodesis of the metatarsophalangeal jointPatient who can benefit from first-line arthrodesis using large-diameter screws |
| Metatarsophalangeal arthrodesis of the hallux by plate | – | Procedure: Arthrodesis of the metatarsophalangeal jointPatient who can benefit from a first intention arthrodesis by dorsal plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw.
Key inclusion criteria (5 listed)
- Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
- Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
- Patient able to understand information related to the study and complete quality of life questionnaires;
- Patient accepting study follow-up visits;
- Patient having been informed and agreeing to participate in the study.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women;
- Patient undergoing lateral ray surgery;
- Patient undergoing revision arthrodesis;
- Patient with a loss of bone substance requiring a graft;
- Patient suffering from chronic inflammatory disease;
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 |
|---|---|---|
| Arthrodesis of the metatarsophalangeal jointIsolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach | Procedure or surgery | Metatarsophalangeal arthrodesis of the hallux by plate, Metatarsophalangeal arthrodesis of the hallux with large diameter screws |
Primary outcome
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)
Time frame: 4 months
Rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation, obtained with different types of osteosynthesis material: dorsal plate and large-diameter compressive screw
Results and safety
The study was stopped early (reason given: only 3 patients were included in this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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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 Deformity, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Mar 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?
The study was stopped early (reason given: only 3 patients were included in this study). Results are not available in the source record.
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?
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw) (time frame: 4 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 27 Mar 2025.