Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures (NCT06599554) | Clinical Trial Compass
CompletedNot Applicable
Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures
Italy107 participantsStarted 2024-12-12
Plain-language summary
From the archives of the IRCCS Rizzoli Orthopedic Institute (SIR2020) all cases of patients undergoing surgical interventions for the reduction and synthesis of fractures of the distal fibula will be retrieved Ankle-fract Version 2.0 8/08/2024 7 isolated or associated with other lesions, treated surgically with placement of anatomical fibula plates and any accessory procedures from 01/01/2019 to 1/1/2024. An overall electronic database will be created and all medical records of these cases will be reviewed.
The pre- and post-operative data of the patients will be analyzed by analyzing the medical records and the post-operative x-rays (x-ray performed as per common clinical practice, present at the institute (IRCCS Istituto Ortopedico Rizzoli) which highlight consolidation of the fracture.
The radiological reports will be read, analyzing when the bony consolidation of the fracture is reported in relation to the time elapsed since the operation.
The questionnaires will be submitted to all patients who have completed the course at 1 year.
All patients who sign the informed consent will be asked to complete the questionnaires either at the time of the follow-up visit by common clinical practice or by telephone, in the event that the patients have exceeded the 1-year follow-up.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate;
* patients of both sexes aged between 18-90 years;
* patients who have given their written informed consent to participate in the study Patients in possession of a post-operative control x-ray examination to evaluate consolidation and alignment (x-ray performed as per common clinical practice).
Exclusion Criteria:
* patients with severe postural instability;
* Patients incapable of understanding or wanting;
* patients with concomitant neurological pathologies that prevent walking and standing
* bedridden patients.
* Lack of written informed consent to participate in the study
* written form to participate in the study
* Physiotherapy not performed
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.