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

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Hallux Valgus
Akin Osteotomy

Treatments

Procedure: AKIN osteotomy with screw fixation
Procedure: AKIN osteotomy without screw fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT05101499
2018-A00717-48

Details and patient eligibility

About

We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.

Full 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).

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

AKIN osteotomy with screw fixation
Experimental group
Treatment:
Procedure: AKIN osteotomy with screw fixation
AKIN osteotomy without screw fixation
Active Comparator group
Treatment:
Procedure: AKIN osteotomy without screw fixation

Trial contacts and locations

1

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Central trial contact

Marie-Hélène Barba; Jean-François Oudet

Data sourced from clinicaltrials.gov

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