Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)
Fixakin
Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2020
CompletedFirst Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2021
CompletedNovember 1, 2021
October 1, 2021
1 year
October 28, 2021
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
AKIN osteotomy with screw fixation
EXPERIMENTALAKIN osteotomy without screw fixation
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- Clinique Blometcollaborator
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
BLOMET clinic
Paris, IDF, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 1, 2021
Study Start
March 18, 2019
Primary Completion
March 18, 2020
Study Completion
November 18, 2021
Last Updated
November 1, 2021
Record last verified: 2021-10