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NCT06338566 Clinical Trial

Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle

Ankle Fractures Clinical Trial

— PROCLOU  

Official title:
Prospective Follow-up of Functional, Bone and Septic Results of Ankle Arthrodesis With Transplanted Nail

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06338566
Other study ID # 2021PPRC10
Secondary ID 2023-A01975-40
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date April 2026

Study information
Verified date March 2024
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting. Patients will be asked to complete a questionnaire during follow-up consultations.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date April 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patient >18 years - having undergone septic nailing in the operating theatre - with social security coverage Exclusion Criteria: - Patient with 6-month follow-up not possible (medical wandering, transient patient), - Patient who has benefited from another means of osteosynthesis - Patients whose long-term return to weight-bearing will not be possible for reasons other than ankle arthrodesis surgery. - Persons able to give consent but unable to read or write French - Opposes participation in the study - Patients whose cognitive capacity does not allow them to answer questionnaires

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Follow-up
Follow-up at D45, 3 months and 6 months, with scoring, radiological monitoring and assessment of wound healing

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Outcome
Type Measure Description Time frame Safety issue
Primary bony outcome of transcalcaneal nailing percentage of patients with aseptic consolidation at 6 months post-op up to 6 months
Secondary functional result of the procedure percentage of patients able to walk again at 6 months post-op up to 6 months
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