Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

Conditions
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Akin Osteotomy, Hallux Valgus

Intervention / Treatment
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* Procedure: AKIN osteotomy with screw fixation
* Procedure: AKIN osteotomy without screw fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AKIN osteotomy with screw fixation<br> | Procedure: AKIN osteotomy with screw fixation<br>* 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.<br>|
| Active Comparator: AKIN osteotomy without screw fixation<br> | Procedure: AKIN osteotomy without screw fixation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year |