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

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: Completed
• Conditions: Ankle Fractures
• Intervention / Treatment: Other: follow up scores

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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	after 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	after 1 year
EQ-5D (EuroQoL) Current Health Assessment	valid tool for measuring a patient's quality of life.	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.	after 1 year

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ankle injuries; foot surgery; ankle fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID 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