Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle (PROCLOU)

March 28, 2024 updated by: Direction Centrale du Service de Santé des Armées

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent ankle surgery and have an ankle arthrodesis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bony outcome of transcalcaneal nailing
Time Frame: up to 6 months
percentage of patients with aseptic consolidation at 6 months post-op
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional result of the procedure
Time Frame: up to 6 months
percentage of patients able to walk again at 6 months post-op
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PPRC10
  • 2023-A01975-40 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankle Fractures

Clinical Trials on Follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe