Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599554
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Outcome and Complications Assessment in the Surgical Treatment of Distal Fibular Fractures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcome and Complications Assessment in the Surgical Treatment of Distal Fibular Fractures an Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20 8082024 7 isolated or associated with other lesions treated surgically with placement of anatomical fibula plates and any accessory procedures from 01012019 to 112024 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None