NCT02984462

Akin Osteotomy With or Without Fixation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2017-05-31
• Primary completion: 2020-09-08
• Completion: 2020-09-08
• First posted: 2016-12-07
• Last updated: 2020-12-01

Locations

1 site across 1 country: France