Metatarsophalangeal Arthrodesis of the Hallux

Terminated

• Conditions: Hallux Deformity
• Interventions: Procedure: Arthrodesis of the metatarsophalangeal joint

• Registration Number: NCT05691075
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Study Start: 2023-03-15
• Primary Completion: 2023-07-16
• Study Completion: 2023-07-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metatarsophalangeal arthrodesis of the hallux with large diameter screws	Arthrodesis of the metatarsophalangeal joint	Patient who can benefit from first-line arthrodesis using large-diameter screws
Metatarsophalangeal arthrodesis of the hallux by plate	Arthrodesis of the metatarsophalangeal joint	Patient who can benefit from a first intention arthrodesis by dorsal plate

Primary Outcome Measures

Name	Time	Method
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)	4 months	Rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation, obtained with different types of osteosynthesis material: dorsal plate and large-diameter compressive screw

Trial Locations

Locations (1)

Clinique Blomet; 🇫🇷 Paris, France