Hallux ValgusAKINNCT02984462
Akin Osteotomy With or Without Fixation
A study testing percutaneous Akin osteotomy in people with Hallux Valgus, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- percutaneous Akin osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2017to 8 Sep 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient which need hallux valgus surgery
Who cannot join
- hallux rigidus
- Trouble of rotation of the the hallux
- Rheumatoid forefoot
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, 33000
About this study
Official title: Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.
The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.
Read the detailed description
It's a prospective monocentric randomized work about forefoot surgery. Every patient included undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed percutaneous Akin osteotomy This study as been approved by Institutional review board; written informed consent is required for all patients before inclusion.
The clinic follow-up of each patients included in the study will be the same of the normal follow-up for this type of surgery in our practice. This includes clinical exam, radiologic exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months after surgery and finally one year after the surgery.
The primary outcome measure which is the first metatarso-phalangeal global mobility will be blindly measure by an observator.
- Conditions
- Hallux Valgus
- Being tested
- percutaneous Akin osteotomy
- Keywords
- percutaneous, non-fixed, Akin ;, osteotomy
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous Akin osteotomyProcedure or surgery
The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.
| Study group | Role | What they receive |
|---|---|---|
| screw fixation | Experimental | Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing. Receives: Procedure: percutaneous Akin osteotomy |
| No fixation | No intervention | Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.
Measured: 12 months
Secondary outcomes (7)
Angle between Metatarsus 1 and Phalanx 1
Measured: 12 months
Angle between Metatarsus 1 and Metatarsus 2
Measured: 12 months
Angle between Phalanx 1 and Phalanx 2
Measured: 12 months
Distal Metatarsal Articular Angle
Measured: 12 months
DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
Measured: 12 months
DM2A angle, calculated at last follow-up by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
Measured: 12 months
Kitaoka Score
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 posted7 Dec 2016 (estimated)
- Study start31 May 2017
- Primary completion8 Sep 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien LUCAS Y HERNADEZ, MD, Principal investigator, University Hospital, BordeauxAntoine BENARD, MD, Study chair, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984462
- Sponsor's protocol ID
- CHUBX 2015/39
- Other IDs
- 2016-A01001-50
- Acronym
- AKIN
- Status last verified
- Nov 2020
- First submitted
- 27 Oct 2016
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02984462
- Acronym / sponsor ID
- AKIN / CHUBX 2015/39
- Conditions
- Hallux Valgus
- Keywords
- percutaneous, non-fixed, Akin ;, osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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 study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.
Detailed description
It's a prospective monocentric randomized work about forefoot surgery. Every patient included undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed percutaneous Akin osteotomy This study as been approved by Institutional review board; written informed consent is required for all patients before inclusion.
The clinic follow-up of each patients included in the study will be the same of the normal follow-up for this type of surgery in our practice. This includes clinical exam, radiologic exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months after surgery and finally one year after the surgery.
The primary outcome measure which is the first metatarso-phalangeal global mobility will be blindly measure by an observator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screw fixation | Experimental | Procedure: percutaneous Akin osteotomySurgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing. |
| No fixation | No intervention | –Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient which need hallux valgus surgery
Key exclusion criteria (4 listed)
- hallux rigidus
- Trouble of rotation of the the hallux
- Rheumatoid forefoot
- 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 |
|---|---|---|
| percutaneous Akin osteotomyThe act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely. | Procedure or surgery | screw fixation |
Primary outcome
Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.
Time frame: 12 months
7 secondary outcomes
Angle between Metatarsus 1 and Phalanx 1
Time frame: 12 months
Angle between Metatarsus 1 and Metatarsus 2
Time frame: 12 months
Angle between Phalanx 1 and Phalanx 2
Time frame: 12 months
Distal Metatarsal Articular Angle
Time frame: 12 months
DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
Time frame: 12 months
DM2A angle, calculated at last follow-up by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
Time frame: 12 months
Kitaoka Score
Time frame: 12 months
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 20 May 2026.
- 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.
Julien LUCAS Y HERNADEZ, MD principal investigator
University Hospital, Bordeaux
Antoine BENARD, MD study chair
Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous Akin osteotomy in people with Hallux Valgus, run by University Hospital, Bordeaux 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 1 inclusion and 4 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 20 May 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?
Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery. (time frame: 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 20 May 2026.