NCT06338566

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 21, 2024

Last Update Submit

March 28, 2024

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

  • bony outcome of transcalcaneal nailing

    percentage of patients with aseptic consolidation at 6 months post-op

    up to 6 months

Secondary Outcomes (1)

  • functional result of the procedure

    up to 6 months

Interventions

Follow-upOTHER

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent ankle surgery and have an ankle arthrodesis.

You may qualify if:

  • Patient \>18 years
  • having undergone septic nailing in the operating theatre
  • with social security coverage

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Design

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

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 29, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share