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

NCT05101499 | Completed

• 1 other identifier: 2018-A00717-48
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Akin Osteotomy; Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AKIN osteotomy with screw fixation

EXPERIMENTAL

Procedure: AKIN osteotomy with screw fixation

AKIN osteotomy without screw fixation

ACTIVE COMPARATOR

Procedure: AKIN osteotomy without screw fixation

Interventions

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 with screw fixation

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.

AKIN osteotomy without screw fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

BLOMET clinic

Paris, IDF, 75015, France

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 1, 2021
• Study Start: March 18, 2019
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

FR (1)