Akin Osteotomy With or Without Fixation

Not Applicable

Completed

• Conditions: Hallux Valgus
• Interventions: Procedure: percutaneous Akin osteotomy

• Registration Number: NCT02984462
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.

Detailed Description

It's a prospective monocentric randomized work about forefoot surgery. Every patient included undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed percutaneous Akin osteotomy This study as been approved by Institutional review board; written informed consent is required for all patients before inclusion.

The clinic follow-up of each patients included in the study will be the same of the normal follow-up for this type of surgery in our practice. This includes clinical exam, radiologic exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months after surgery and finally one year after the surgery.

The primary outcome measure which is the first metatarso-phalangeal global mobility will be blindly measure by an observator.

Study Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-07
• Study Start: 2017-05-31
• Primary Completion: 2020-09-08
• Study Completion: 2020-09-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• patient which need hallux valgus surgery

Exclusion Criteria

• hallux rigidus
• Trouble of rotation of the the hallux
• Rheumatoid forefoot
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
screw fixation	percutaneous Akin osteotomy	Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing.

Primary Outcome Measures

Name	Time	Method
Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.	12 months

Secondary Outcome Measures

Name	Time	Method
Distal Metatarsal Articular Angle	12 months
Angle between Metatarsus 1 and Phalanx 1	12 months
DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface	12 months
Kitaoka Score	12 months
Angle between Phalanx 1 and Phalanx 2	12 months
DM2A angle, calculated at last follow-up by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface	12 months
Angle between Metatarsus 1 and Metatarsus 2	12 months

Trial Locations

Locations (1)

University Hospital of Bordeaux - Hospital Pellegrin; 🇫🇷 Bordeaux, France