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Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin) (Fixakin)

Primary Purpose

Akin Osteotomy, Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AKIN osteotomy with screw fixation
AKIN osteotomy without screw fixation
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Akin Osteotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient over 18 years-old
  • Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder,
  • First line surgery,
  • Absence of metatarsophalangeal osteoarthritis,
  • Persistence of mobility of the hallux metatarsophalangeal gland,
  • Subject benefiting from a social protection insurance
  • Patient having signed the free and informed consent / Patient having given his express consent / Patient having been informed and not opposing this research.

Exclusion Criteria:

  • Rotation disorder,
  • Rheumatoid foot,
  • Hallux rigidus.
  • Patient participating in another clinical study
  • Minors:
  • Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
  • Pregnant, breastfeeding or parturient woman;
  • Hospitalized without consent.

Sites / Locations

  • BLOMET clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AKIN osteotomy with screw fixation

AKIN osteotomy without screw fixation

Arm Description

Outcomes

Primary Outcome Measures

Overall mobility of the metatarsophalangeal hallux joint in degre
Overall mobility of the metatarsophalangeal hallux joint in degree, one year after surgery, measured by a goniometer, as the amplitude between plantar flexion and dorsiflexion.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2021
Last Updated
October 28, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
Clinique Blomet, European Clinical Trial Experts Network
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1. Study Identification

Unique Protocol Identification Number
NCT05101499
Brief Title
Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)
Acronym
Fixakin
Official Title
Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
November 18, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Clinique Blomet, European Clinical Trial Experts Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.
Detailed Description
Compare the screw fixation technique of Akin's osteotomy, compared to the technique without fixation, on the postoperative mobility of the metatarsophalangeal joint of the hallux at one year postoperatively in patients ( patients operated on for an isolated hallux valgus, that is to say without any associated lateral movement, by percutaneous technique (MICA or PERC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Akin Osteotomy, Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AKIN osteotomy with screw fixation
Arm Type
Experimental
Arm Title
AKIN osteotomy without screw fixation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
AKIN osteotomy with screw fixation
Intervention Description
A simple skin speck is made on the medial aspect of the hallux, in the metaphyseal area, using a 3 mm beaver blade. The tissue is lifted from the bone using an elevator medially and dorsally on the phalanx. A Shannon 2x12 mm burr is then positioned transversely by making the osteotomy which must preserve a lateral hinge, a guarantee of stability in the event of non-fixation. Fixation with a screw will be effected by another skin speckle allowing access to the infero-medial area of the phalangeal base. A pre-hole can be made with the same bur to facilitate the introduction of the guide wire for osteosynthesis, which is not specific.
Intervention Type
Procedure
Intervention Name(s)
AKIN osteotomy without screw fixation
Intervention Description
This is the same procedure as the procedure under study, without the fixation by a target: a simple skin speck is performed on the medial face of the hallux, in the metaphyseal area using a beaver blade. of 3 mm. The tissue is lifted from the bone using an elevator medially and dorsally on the phalanx. A Shannon 2x12 mm burr is then positioned transversely by making the osteotomy which must preserve a lateral hinge, a guarantee of stability in the event of non-fixation.
Primary Outcome Measure Information:
Title
Overall mobility of the metatarsophalangeal hallux joint in degre
Description
Overall mobility of the metatarsophalangeal hallux joint in degree, one year after surgery, measured by a goniometer, as the amplitude between plantar flexion and dorsiflexion.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years-old Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder, First line surgery, Absence of metatarsophalangeal osteoarthritis, Persistence of mobility of the hallux metatarsophalangeal gland, Subject benefiting from a social protection insurance Patient having signed the free and informed consent / Patient having given his express consent / Patient having been informed and not opposing this research. Exclusion Criteria: Rotation disorder, Rheumatoid foot, Hallux rigidus. Patient participating in another clinical study Minors: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
BLOMET clinic
City
Paris
State/Province
IDF
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
First Name & Middle Initial & Last Name & Degree
Jean Francois OUDET
Phone
+33683346567
Ext
+33683346567
Email
jf.oudet@ecten.eu

12. IPD Sharing Statement

Learn more about this trial

Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)

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