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

Hallux Valgus Clinical Trial

— Fixakin  

Official title:

Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101499
• Other study ID #: 2018-A00717-48
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: November 18, 2021

Study information

• Verified date: October 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: November 18, 2021
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	BLOMET clinic	Paris	IDF

Sponsors (3)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Clinique Blomet, European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year