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

NCT ID: NCT06599554

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2025-09-23

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients

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

follow up scores

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Stefano Zaffagnini

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy

Countries

Italy

Other Identifiers

ANKLE-FRACT

Identifier Type: -

Identifier Source: org_study_id