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Completed

NCT Number: NCT02984462

Akin Osteotomy With or Without Fixation

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.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Bordeaux - Hospital Pellegrin

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient which need hallux valgus surgery

Exclusion criteria

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

Treatment and study plan

percutaneous Akin osteotomy

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.

Primary outcomes

  1. Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.

    Time frame: 12 months

Secondary outcomes

  1. Angle between Metatarsus 1 and Phalanx 1

    Time frame: 12 months

  2. Angle between Metatarsus 1 and Metatarsus 2

    Time frame: 12 months

  3. Angle between Phalanx 1 and Phalanx 2

    Time frame: 12 months

  4. Distal Metatarsal Articular Angle

    Time frame: 12 months

  5. DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface

    Time frame: 12 months

  6. 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

    Time frame: 12 months

  7. Kitaoka Score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.

Acronym: AKIN

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2016
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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