Clinical trial NCT06599554: Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures
Official title: Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Fractures
Keywords: ankle injuries
ankle fractures
foot surgery
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Foot and Ankle Disability Index
timeFrame: after 1 year
Secondary outcomes:
measure: The American Orthopedic Foot and Ankle Score
timeFrame: after 1 year
measure: Visual Analog Score
timeFrame: after 1 year
measure: 12-Item Short Form Survey
timeFrame: after 1 year
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: after 1 year
measure: x-rays analysis
timeFrame: after 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: