Akin Osteotomy With or Without Fixation

NCT ID: NCT02984462

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2020-09-08

Brief Summary

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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

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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.

Conditions

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Hallux Valgus

Keywords

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percutaneous non-fixed Akin ; osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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screw fixation

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

Group Type EXPERIMENTAL

percutaneous Akin osteotomy

Intervention Type PROCEDURE

The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.

No fixation

Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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percutaneous Akin osteotomy

The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patient which need hallux valgus surgery

Exclusion Criteria

* hallux rigidus
* Trouble of rotation of the the hallux
* Rheumatoid forefoot
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien LUCAS Y HERNADEZ, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Antoine BENARD, MD

Role: STUDY_CHAIR

Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux

Locations

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University Hospital of Bordeaux - Hospital Pellegrin

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2015/39

Identifier Type: -

Identifier Source: org_study_id