Metatarsophalangeal Arthrodesis of the Hallux

Last updated: March 24, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Terminated

Phase

N/A

Condition

Birth Defects

Holoprosencephaly

Treatment

Arthrodesis of the metatarsophalangeal joint

Clinical Study ID

NCT05691075
2022-A02518-35
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, halluxvarus or hallux rigidus by percutaneous or conventional approach;

  • Patient who can benefit from first-line arthrodesis using a dorsal plate orlarge-diameter screw;

  • Patient able to understand information related to the study and complete quality oflife questionnaires;

  • Patient accepting study follow-up visits;

  • Patient having been informed and agreeing to participate in the study.

Exclusion

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 ofliberty.

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: Arthrodesis of the metatarsophalangeal joint
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
July 16, 2023

Study 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.

Connect with a study center

  • Clinique Blomet

    Paris, 75015
    France

    Site Not Available

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