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

Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

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

Study Overview

• Status: Completed
• Conditions: Akin Osteotomy; Hallux Valgus
• Intervention / Treatment: Procedure: AKIN osteotomy with screw fixation; Procedure: AKIN osteotomy without screw fixation

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).

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75015
      • BLOMET clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AKIN osteotomy with screw fixation	Procedure: 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.
Active Comparator: AKIN osteotomy without screw fixation	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network; Clinique Blomet

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: 2018-A00717-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No