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

Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05101499
Acronym
Fixakin
Enrollment
54
Registered
2021-11-01
Start date
2019-03-18
Completion date
2023-11-08
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Akin Osteotomy, Hallux Valgus

Brief 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.

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).

Interventions

PROCEDUREAKIN 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.

PROCEDUREAKIN 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.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall mobility of the metatarsophalangeal hallux joint in degre1 yearOverall mobility of the metatarsophalangeal hallux joint in degree, one year after surgery, measured by a goniometer, as the amplitude between plantar flexion and dorsiflexion.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026