Metatarsophalangeal Arthrodesis of the Hallux

NCT05691075 | Terminated

• 1 other identifier: 2022-A02518-35
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Deformity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Arthrodesis of the metatarsophalangeal joint 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; Metatarsophalangeal arthrodesis of the hallux with large diameter screws

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique Blomet

Paris, 75015, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: March 15, 2023
• Primary Completion: July 16, 2023
• Study Completion: July 16, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)