Metatarsophalangeal Arthrodesis of the Hallux (ARTHRODESE)

Metatarsophalangeal Arthrodesis of the Hallux : Observational Study Evaluating the Efficacy and Tolerance of Synthetic Methods Using Dorsal Plate and Large-diameter Screws

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.

Study Overview

• Status: Terminated
• Conditions: Hallux Deformity
• Intervention / Treatment: Procedure: Arthrodesis of the metatarsophalangeal joint

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Clinique Blomet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metatarsophalangeal arthrodesis of the hallux with large diameter screws; Patient who can benefit from first-line arthrodesis using large-diameter screws	Procedure: Arthrodesis of the metatarsophalangeal joint; 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	Procedure: Arthrodesis of the metatarsophalangeal joint; Isolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)	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	4 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): July 16, 2023
• Study Completion (Actual): July 16, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2022-A02518-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No