Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT03741556
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2018-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Factors Following Ankle Fractures
Sponsor:
Sygehus Lillebaelt
Organization:
Study Overview
Official Title:
Recovery Following Ankle Fracture Reported by Patient Report Outcome
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.
Detailed Description:
Aim of study:
To identify prognostic factors associated with a worse outcome following ankle fractures.
Method:
All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:
Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.
Study participants will at time of diagnosis and 6, 12, 52 and 104 weeks following the injury received a questionaire with Manchester foot and ankle questionnaire (MOXFQ), Self-reported foot and ankle questionnaire (SEFAS), Olerud Molander Ankle Score (OMAS) and Forgotten Joint Score (FJS).
Which of the questionaire that should be used in the study will be determined when the questionaires have been compared in a different study.
To identify prognostic factors associated with a worse outcome following ankle fractures.
Method:
All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:
Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.
Study participants will at time of diagnosis and 6, 12, 52 and 104 weeks following the injury received a questionaire with Manchester foot and ankle questionnaire (MOXFQ), Self-reported foot and ankle questionnaire (SEFAS), Olerud Molander Ankle Score (OMAS) and Forgotten Joint Score (FJS).
Which of the questionaire that should be used in the study will be determined when the questionaires have been compared in a different study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: