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Metatarsophalangeal Arthrodesis of the Hallux

Recruiting
18 years of age
Both
Phase N/A

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Overview

The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.

Description

The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw.

Patients will be divided into two groups:

  • patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
  • patient undergoing arthrodesis of the hallux by plate (group B)

This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.

Eligibility

Inclusion Criteria:

  • Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
  • Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
  • Patient able to understand information related to the study and complete quality of life questionnaires;
  • Patient accepting study follow-up visits;
  • Patient having been informed and agreeing to participate in the study.

Exclusion Criteria:

  • Pregnant or breastfeeding women;
  • Patient undergoing lateral ray surgery;
  • Patient undergoing revision arthrodesis;
  • Patient with a loss of bone substance requiring a graft;
  • Patient suffering from chronic inflammatory disease;
  • Patient treated with long-term immunosuppressive or corticosteroid treatments;
  • Patient under guardianship or curatorship, or under a regime of deprivation of liberty.

Study details

Hallux Deformity

NCT05691075

GCS Ramsay Santé pour l'Enseignement et la Recherche

26 January 2024

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