Akin Osteotomy With or Without Fixation (AKIN)
Primary Purpose
Hallux Valgus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
percutaneous Akin osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring percutaneous, non-fixed, Akin ;, osteotomy
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
Sites / Locations
- University Hospital of Bordeaux - Hospital Pellegrin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
screw fixation
No fixation
Arm Description
Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing.
Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing.
Outcomes
Primary Outcome Measures
Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.
Secondary Outcome Measures
Angle between Metatarsus 1 and Phalanx 1
Angle between Metatarsus 1 and Metatarsus 2
Angle between Phalanx 1 and Phalanx 2
Distal Metatarsal Articular Angle
DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
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
Kitaoka Score
Full Information
NCT ID
NCT02984462
First Posted
October 27, 2016
Last Updated
November 27, 2020
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT02984462
Brief Title
Akin Osteotomy With or Without Fixation
Acronym
AKIN
Official Title
Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
September 8, 2020 (Actual)
Study Completion Date
September 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
percutaneous, non-fixed, Akin ;, osteotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
screw fixation
Arm Type
Experimental
Arm Description
Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing.
Arm Title
No fixation
Arm Type
No Intervention
Arm Description
Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing.
Intervention Type
Procedure
Intervention Name(s)
percutaneous Akin osteotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Angle between Metatarsus 1 and Phalanx 1
Time Frame
12 months
Title
Angle between Metatarsus 1 and Metatarsus 2
Time Frame
12 months
Title
Angle between Phalanx 1 and Phalanx 2
Time Frame
12 months
Title
Distal Metatarsal Articular Angle
Time Frame
12 months
Title
DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
Time Frame
12 months
Title
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
Time Frame
12 months
Title
Kitaoka Score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien LUCAS Y HERNADEZ, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Bordeaux - Hospital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Akin Osteotomy With or Without Fixation
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