Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures

January 29, 2026 updated by: Stefano Zaffagnini, Istituto Ortopedico Rizzoli

Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures: an Observational Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients undergoing surgery for reduction and synthesis of fibula fracture treated with anatomical fibula plate from 01/01/2019 to 01/01/2024 operated at SC Orthopedic and Traumatology Clinic II, with minimum follow-up of 1 year, with possibly associated with other surgical procedures made necessary due to the trauma

Description

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients
patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate
Other: follow up scores

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Foot and Ankle Disability Index
Time Frame: after 1 year
It is a self-reported questionnaire used to assess functional limitations and disabilities associated with foot and ankle conditions. The FADI consists of two parts: the main part with 26 questions and the additional sports module with 8 questions. Each question is rated on a 5-point scale (0 to 4), with 0 indicating the most difficulty and 4 indicating no difficulty. The scores for each question are added and converted to a percentage, with a higher percentage indicating better function. It is rated on a total of 104 points, with a score of 0 indicating maximum disability and a score of 104 indicating no disability
after 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The American Orthopedic Foot and Ankle Score
Time Frame: after 1 year
clinical and functional evaluation for ankle and foot most validated and used in literature. There are 4 versions depending on the anatomical region to be evaluated: ankle and hindfoot, midfoot, first toe, last 4 toes. In this case the ankle and hindfoot version will be used. The score consists of 9 questions grouped into 3 categories for a total of 100 maximum points: Pain (up to 40 points), Function (up to 50 points) and Alignment (up to 10 points); 100 points represent the best possible clinical-functional condition and the absence of symptoms, 0 points represent the worst possible clinical-functional condition. It is a tool that combines the subjective component of the patient with the objective evaluation by the doctor.
after 1 year
Visual Analog Score
Time Frame: after 1 year
visual representation of the extent of pain that the patient subjectively feels. The VAS is represented by a 10 cm long line in the original validated version, with or without notches corresponding to each centimeter. One end indicates the absence of pain and corresponds to 0, the other end indicates the worst pain imaginable and corresponds to 10. The scale is filled in manually by the patient who is asked to draw a sign on the line that represents the perceived pain . The distance measured from the 0 end corresponds to the subjective measurement of pain.
after 1 year
12-Item Short Form Survey
Time Frame: after 1 year
short version of the SF-36 questionnaire (link). Through 12 of the 36 questions of the original questionnaire it allows us to investigate the two synthetic indices, PCS Physical Component Summary for the Physical State and MCS Mental Component Summary for the Mental State. The greatest strengths of this questionnaire are its brevity and relative ease of use. In Italy the questionnaire was used among other things in 2000 in a multipurpose ISTAT survey on the health status of Italians and a reference database is available with data on a sample of 61,434 subjects representative of the Italian population. Even for this short form, the literature is full of experiences and studies that demonstrate its validity and reliability.
after 1 year
EQ-5D (EuroQoL) Current Health Assessment
Time Frame: after 1 year
valid tool for measuring a patient's quality of life.
after 1 year
x-rays analysis
Time Frame: after 1 year
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.
after 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANKLE-FRACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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