CompletedNot Applicable

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

France54 participantsStarted 2019-03-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall mobility of the metatarsophalangeal hallux joint in degre

Timeframe: 1 year

Trial details

NCT IDNCT05101499

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-08

View on ClinicalTrials.gov More Akin Osteotomy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.