Ankle FracturesNCT06599554
Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures
An observational study of Ankle Fractures, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- follow up scores
- How many people
- 107 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2024to 23 Sep 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Ankle Fractures
- Being tested
- follow up scores
- Keywords
- ankle injuries, ankle fractures, foot surgery
- Medical subject headings
- Ankle Fractures, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up scoresOther
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 group | Role | What they receive |
|---|---|---|
| patients | patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate Receives: Other: follow up scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Disability Index
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
Measured: after 1 year
Secondary outcomes (5)
The American Orthopedic Foot and Ankle Score
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.
Measured: after 1 year
Visual Analog Score
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.
Measured: after 1 year
12-Item Short Form Survey
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.
Measured: after 1 year
EQ-5D (EuroQoL) Current Health Assessment
valid tool for measuring a patient's quality of life.
Measured: after 1 year
x-rays analysis
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.
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Dec 2024
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
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.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599554
- Sponsor's protocol ID
- ANKLE-FRACT
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures: an Observational Study
- ClinicalTrials.gov ID
- NCT06599554
- Acronym / sponsor ID
- ANKLE-FRACT
- Conditions
- Ankle Fractures
- Keywords
- ankle injuries, ankle fractures, foot surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 19 Sep 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: follow up scorespatients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate;
Key exclusion criteria (7 listed)
- patients with severe postural instability;
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 up scoresThe 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 | Other | patients |
Primary outcome
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
5 secondary outcomes
The American Orthopedic Foot and Ankle Score
Time frame: after 1 year
Visual Analog Score
Time frame: after 1 year
12-Item Short Form Survey
Time frame: after 1 year
EQ-5D (EuroQoL) Current Health Assessment
Time frame: after 1 year
x-rays analysis
Time frame: after 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 7 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Foot and Ankle Disability Index (time frame: after 1 year). 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 2 Feb 2026.