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

Last updated: October 28, 2021
Sponsor: Ramsay Générale de Santé
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bunion

Treatment

N/A

Clinical Study ID

NCT05101499
2018-A00717-48
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient over 18 years-old
  • Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / orpercutaneous 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 expressconsent / Patient having been informed and not opposing this research.

Exclusion

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 theirliberty by judicial or administrative decision;
  • Pregnant, breastfeeding or parturient woman;
  • Hospitalized without consent.

Study Design

Total Participants: 108
Study Start date:
March 18, 2019
Estimated Completion Date:
November 18, 2021

Study 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).

Connect with a study center

  • BLOMET clinic

    Paris, IDF 75015
    France

    Active - Recruiting

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