AKIN: Akin Osteotomy With or Without Fixation

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT02984462

Collaborator

(none)

Enrollment

Location

Arms

39.3

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus	Procedure: percutaneous Akin osteotomy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 31, 2017

Actual Primary Completion Date :

Sep 8, 2020

Actual Study Completion Date :

Sep 8, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: screw fixation

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

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.

No Intervention: No fixation

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

Outcome Measures

Primary Outcome Measures

Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery. [12 months]

Secondary Outcome Measures

Angle between Metatarsus 1 and Phalanx 1 [12 months]
Angle between Metatarsus 1 and Metatarsus 2 [12 months]
Angle between Phalanx 1 and Phalanx 2 [12 months]
Distal Metatarsal Articular Angle [12 months]
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]
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]
Kitaoka Score [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Bordeaux - Hospital Pellegrin	Bordeaux		France	33000

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator: Julien LUCAS Y HERNADEZ, MD, University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux