Skip to main content
OpenTrials
Completed

NCT Number: NCT05101499

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

We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Akin Osteotomy Foot Deformities Hallux Valgus Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BLOMET clinic

Paris, IDF, 75015, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AKIN osteotomy with screw fixation

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

Acronym: Fixakin

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.