ARTHRODESE: Metatarsophalangeal Arthrodesis of the Hallux
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
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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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Rate of bone fusion [4 months]
Rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
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Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
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Patient able to understand information related to the study and complete quality of life questionnaires;
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Patient accepting study follow-up visits;
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Patient having been informed and agreeing to participate in the study.
Exclusion Criteria:
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Pregnant or breastfeeding women;
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Patient undergoing lateral ray surgery;
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Patient undergoing revision arthrodesis;
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Patient with a loss of bone substance requiring a graft;
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Patient suffering from chronic inflammatory disease;
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Patient treated with long-term immunosuppressive or corticosteroid treatments;
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Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-A02518-35