Ankle FracturesPROCLOUNCT06338566
Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle
An observational study of Ankle Fractures, run by Direction Centrale du Service de Santé des Armées.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Follow-up
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent ankle surgery and have an ankle arthrodesis.
Who may be able to join
- Patient >18 years
- having undergone septic nailing in the operating theatre
- with social security coverage
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Ankle Fractures
- Being tested
- Follow-up
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Follow-up at D45, 3 months and 6 months, with scoring, radiological monitoring and assessment of wound healing
What is being measured
The primary outcome is the main question the study is designed to answer.
bony outcome of transcalcaneal nailing
percentage of patients with aseptic consolidation at 6 months post-op
Measured: up to 6 months
Secondary outcomes (1)
functional result of the procedure
percentage of patients able to walk again at 6 months post-op
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338566
- Sponsor's protocol ID
- 2021PPRC10
- Other IDs
- 2023-A01975-40
- Acronym
- PROCLOU
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up of Functional, Bone and Septic Results of Ankle Arthrodesis With Transplanted Nail
- ClinicalTrials.gov ID
- NCT06338566
- Acronym / sponsor ID
- PROCLOU / 2021PPRC10
- Conditions
- Ankle Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent ankle surgery and have an ankle arthrodesis.
Key inclusion criteria (3 listed)
- Patient >18 years
- having undergone septic nailing in the operating theatre
- with social security coverage
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-upFollow-up at D45, 3 months and 6 months, with scoring, radiological monitoring and assessment of wound healing | Other | – |
Primary outcome
bony outcome of transcalcaneal nailing
Time frame: up to 6 months
percentage of patients with aseptic consolidation at 6 months post-op
1 secondary outcome
functional result of the procedure
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures, run by Direction Centrale du Service de Santé des Armées.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bony outcome of transcalcaneal nailing (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.