Akin Osteotomy With or Without Fixation

Hallux Valgus Clinical Trial

— AKIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984462
• Other study ID #: CHUBX 2015/39
• Status: Completed
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: September 8, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 8, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patient which need hallux valgus surgery

Exclusion Criteria:

• hallux rigidus

• Trouble of rotation of the the hallux

• Rheumatoid forefoot

• Pregnant women

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Bordeaux - Hospital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.		12 months
Secondary	Angle between Metatarsus 1 and Phalanx 1		12 months
Secondary	Angle between Metatarsus 1 and Metatarsus 2		12 months
Secondary	Angle between Phalanx 1 and Phalanx 2		12 months
Secondary	Distal Metatarsal Articular Angle		12 months
Secondary	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
Secondary	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
Secondary	Kitaoka Score		12 months