Metatarsophalangeal Arthrodesis of the Hallux

NCT ID: NCT05691075

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-07-16

Brief 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.

Detailed 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.

Conditions

Hallux Deformity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Metatarsophalangeal arthrodesis of the hallux with large diameter screws

Patient who can benefit from first-line arthrodesis using large-diameter screws

Arthrodesis of the metatarsophalangeal joint

Intervention Type: PROCEDURE

Isolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach

Metatarsophalangeal arthrodesis of the hallux by plate

Patient who can benefit from a first intention arthrodesis by dorsal plate

Arthrodesis of the metatarsophalangeal joint

Intervention Type: PROCEDURE

Isolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach

Interventions

Arthrodesis of the metatarsophalangeal joint

Isolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Blomet

Paris, , France

Countries

France

Other Identifiers

2022-A02518-35

Identifier Type: -

Identifier Source: org_study_id