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

NCT06599554 | Completed

• 1 other identifier: ANKLE-FRACT
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Fractures

Keywords

ankle injuries; ankle fractures; foot surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The American Orthopedic Foot and Ankle Score

  after 1 year

• Visual Analog Score

  after 1 year

• 12-Item Short Form Survey

  after 1 year

• EQ-5D (EuroQoL) Current Health Assessment

  after 1 year

• x-rays analysis

  after 1 year

Study Arms (1)

patients

patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate

Other: follow up scores

Interventions

follow up scores OTHER

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

patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: December 12, 2024
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-09

Locations

IT (1)