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Akin Osteotomy With or Without Fixation (AKIN)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Hallux Valgus

Treatments

Procedure: percutaneous Akin osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02984462
CHUBX 2015/39

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient which need hallux valgus surgery

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

58 participants in 2 patient groups

screw fixation
Experimental group
Description:
Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing.
Treatment:
Procedure: percutaneous Akin osteotomy
No fixation
No Intervention group
Description:
Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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