Akin OsteotomyFixakinNCT05101499
Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)
A study testing AKIN osteotomy with screw fixation and AKIN osteotomy without screw fixation in people with Akin Osteotomy and Hallux Valgus, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Akin Osteotomy, Hallux Valgus
- What is being tested?
- AKIN osteotomy with screw fixation and AKIN osteotomy without screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2019to 8 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patient over 18 years-old
- Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder,
- First line surgery,
- Absence of metatarsophalangeal osteoarthritis,
- Persistence of mobility of the hallux metatarsophalangeal gland,
- Subject benefiting from a social protection insurance
- Patient having signed the free and informed consent / Patient having given his express consent / Patient having been informed and not opposing this research.
Who cannot join
- Rotation disorder,
- Rheumatoid foot,
- Hallux rigidus.
- Patient participating in another clinical study
- Minors:
- Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
- Pregnant, breastfeeding or parturient woman;
- Hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation
We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.
Read the detailed description
Compare the screw fixation technique of Akin's osteotomy, compared to the technique without fixation, on the postoperative mobility of the metatarsophalangeal joint of the hallux at one year postoperatively in patients ( patients operated on for an isolated hallux valgus, that is to say without any associated lateral movement, by percutaneous technique (MICA or PERC).
- Conditions
- Akin Osteotomy, Hallux Valgus
- Being tested
- AKIN osteotomy with screw fixation, AKIN osteotomy without screw fixation
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKIN osteotomy with screw fixationProcedure or surgery
A simple skin speck is made on the medial aspect of the hallux, in the metaphyseal area, using a 3 mm beaver blade. The tissue is lifted from the bone using an elevator medially and dorsally on the phalanx. A Shannon 2x12 mm burr is then positioned transversely by making the osteotomy which must preserve a lateral hinge, a guarantee of stability in the event of non-fixation.
Fixation with a screw will be effected by another skin speckle allowing access to the infero-medial area of the phalangeal base. A pre-hole can be made with the same bur to facilitate the introduction of the guide wire for osteosynthesis, which is not specific.
AKIN osteotomy without screw fixationProcedure or surgery
This is the same procedure as the procedure under study, without the fixation by a target: a simple skin speck is performed on the medial face of the hallux, in the metaphyseal area using a beaver blade. of 3 mm. The tissue is lifted from the bone using an elevator medially and dorsally on the phalanx. A Shannon 2x12 mm burr is then positioned transversely by making the osteotomy which must preserve a lateral hinge, a guarantee of stability in the event of non-fixation.
| Study group | Role | What they receive |
|---|---|---|
| AKIN osteotomy with screw fixation | Experimental | Not described Receives: Procedure: AKIN osteotomy with screw fixation |
| AKIN osteotomy without screw fixation | Active comparator | Not described Receives: Procedure: AKIN osteotomy without screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mobility of the metatarsophalangeal hallux joint in degre
Overall mobility of the metatarsophalangeal hallux joint in degree, one year after surgery, measured by a goniometer, as the amplitude between plantar flexion and dorsiflexion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start18 Mar 2019
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Akin OsteotomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101499
- Sponsor's protocol ID
- 2018-A00717-48
- Acronym
- Fixakin
- Status last verified
- Jul 2026
- First submitted
- 28 Oct 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation
- ClinicalTrials.gov ID
- NCT05101499
- Acronym / sponsor ID
- Fixakin / 2018-A00717-48
- Conditions
- Akin Osteotomy, Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 1 Nov 2021 (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.
We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.
Detailed description
Compare the screw fixation technique of Akin's osteotomy, compared to the technique without fixation, on the postoperative mobility of the metatarsophalangeal joint of the hallux at one year postoperatively in patients ( patients operated on for an isolated hallux valgus, that is to say without any associated lateral movement, by percutaneous technique (MICA or PERC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKIN osteotomy with screw fixation | Experimental | Procedure: AKIN osteotomy with screw fixation |
| AKIN osteotomy without screw fixation | Active comparator | Procedure: AKIN osteotomy without screw fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years-old
- Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder,
- First line surgery,
- Absence of metatarsophalangeal osteoarthritis,
- Persistence of mobility of the hallux metatarsophalangeal gland,
Key exclusion criteria (8 listed)
- Rotation disorder,
- Rheumatoid foot,
- Hallux rigidus.
- Patient participating in another clinical study
- Minors:
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 |
|---|---|---|
| AKIN osteotomy with screw fixationA simple skin speck is made on the medial aspect of the hallux, in the metaphyseal area, using a 3 mm beaver blade. The tissue is lifted from the bone using an elevator medially and dorsally on the phalanx. A Shannon 2x12 mm burr is then positioned transversely by making the osteotomy which must preserve a lateral hinge, a guarantee of stability in the event of non-fixation. Fixation with a screw will be effected by another skin speckle allowing access to the infero-medial area of the phalangeal base. A pre-hole can be made with the same bur to facilitate the introduction of the guide wire for osteosynthesis, which is not specific. | Procedure or surgery | AKIN osteotomy with screw fixation |
| AKIN osteotomy without screw fixationThis is the same procedure as the procedure under study, without the fixation by a target: a simple skin speck is performed on the medial face of the hallux, in the metaphyseal area using a beaver blade. of 3 mm. The tissue is lifted from the bone using an elevator medially and dorsally on the phalanx. A Shannon 2x12 mm burr is then positioned transversely by making the osteotomy which must preserve a lateral hinge, a guarantee of stability in the event of non-fixation. | Procedure or surgery | AKIN osteotomy without screw fixation |
Primary outcome
Overall mobility of the metatarsophalangeal hallux joint in degre
Time frame: 1 year
Overall mobility of the metatarsophalangeal hallux joint in degree, one year after surgery, measured by a goniometer, as the amplitude between plantar flexion and dorsiflexion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Related trials for Akin Osteotomy
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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?
A study testing AKIN osteotomy with screw fixation and AKIN osteotomy without screw fixation in people with Akin Osteotomy and Hallux Valgus, 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 7 inclusion and 8 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 16 Jul 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall mobility of the metatarsophalangeal hallux joint in degre (time frame: 1 year). 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 16 Jul 2026.