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
• 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
• 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

Related Conditions & MeSH terms

• Ankle Fractures

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