Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)
NCT ID: NCT05101499
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2019-03-18
2021-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AKIN osteotomy with screw fixation
AKIN osteotomy with screw fixation
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 fixation
AKIN osteotomy without screw fixation
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.
Interventions
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AKIN osteotomy with screw fixation
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 fixation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Clinique Blomet
UNKNOWN
European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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BLOMET clinic
Paris, IDF, France
Countries
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Central Contacts
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Facility Contacts
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Marie Barba
Role: primary
Jean Francois OUDET
Role: backup
Other Identifiers
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2018-A00717-48
Identifier Type: -
Identifier Source: org_study_id