Clinical trial NCT02984462: Akin Osteotomy With or Without Fixation
Official title: Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: percutaneous
non-fixed
Akin ;
osteotomy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* patient which need hallux valgus surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.
timeFrame: 12 months
Secondary outcomes:
measure: Angle between Metatarsus 1 and Phalanx 1
timeFrame: 12 months
measure: Angle between Metatarsus 1 and Metatarsus 2
timeFrame: 12 months
measure: Angle between Phalanx 1 and Phalanx 2
timeFrame: 12 months
measure: Distal Metatarsal Articular Angle
timeFrame: 12 months
measure: DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Kitaoka Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Hospital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien LUCAS Y HERNADEZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: