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

Not Applicable

• Conditions: Akin Osteotomy; Hallux Valgus
• Interventions: Procedure: AKIN osteotomy with screw fixation; Procedure: AKIN osteotomy without screw fixation

• Registration Number: NCT05101499
• Lead Sponsor: Ramsay Générale de Santé

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).

Study Timeline

• Study Start: 2019-03-18
• Primary Completion: 2020-03-18
• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-01
• Last Update Posted: 2021-11-01
• Study Completion: 2021-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKIN osteotomy with screw fixation	AKIN osteotomy with screw fixation	-
AKIN osteotomy without screw fixation	AKIN osteotomy without screw fixation	-

Primary Outcome Measures

Name	Time	Method
Overall mobility of the metatarsophalangeal hallux joint in degre	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.

Trial Locations

Locations (1)

BLOMET clinic; 🇫🇷 Paris, IDF, France