Metatarsophalangeal Arthrodesis of the Hallux

Hallux Deformity Clinical Trial

— ARTHRODESE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691075
• Other study ID #: 2022-A02518-35
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Julien BELDAME, MD
• Phone: 276203095
• Email: julien.beldame[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Hallux Deformity

Intervention

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

Locations

Country	Name	City	State
France	Clinique Blomet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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