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

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Recruiting

CT.gov ID

NCT05101499

Collaborator

Clinique Blomet (Other), European Clinical Trial Experts Network (Other)

108

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Akin Osteotomy Hallux Valgus	Procedure: AKIN osteotomy with screw fixation Procedure: AKIN osteotomy without screw fixation	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

Actual Study Start Date :

Mar 18, 2019

Actual Primary Completion Date :

Mar 18, 2020

Anticipated Study Completion Date :

Nov 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AKIN osteotomy with screw fixation	Procedure: AKIN osteotomy with screw fixation 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.
Active Comparator: AKIN osteotomy without screw fixation	Procedure: AKIN osteotomy without screw fixation 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.

Arm

Intervention/Treatment

Experimental: AKIN osteotomy with screw fixation

Procedure: AKIN osteotomy with screw fixation

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.

Active Comparator: AKIN osteotomy without screw fixation

Procedure: AKIN osteotomy without screw fixation

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.

Outcome Measures

Primary Outcome Measures

Overall mobility of the metatarsophalangeal hallux joint in degre [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BLOMET clinic	Paris	IDF	France	75015

Sponsors and Collaborators

Ramsay Générale de Santé
Clinique Blomet
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05101499

Other Study ID Numbers:

2018-A00717-48

First Posted:

Nov 1, 2021

Last Update Posted:

Nov 1, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hallux Valgus

Study Results

No Results Posted as of Nov 1, 2021