Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-30 @ 6:16 AM
Study NCT ID:
NCT05325268
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
Sponsor:
Technische Universität Dresden
Organization:
Study Overview
Official Title:
Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
Status:
COMPLETED
Status Verified Date:
2022-04
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:
Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.
Detailed Description:
A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.
In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score \[DASH\], MEPS \[Mayo Elbow Performance Score\], Oxford Elbow Score \[OES\], Pain, Subjective Elbow Score) and functionality (range of motion \[ROM\], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.
In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score \[DASH\], MEPS \[Mayo Elbow Performance Score\], Oxford Elbow Score \[OES\], Pain, Subjective Elbow Score) and functionality (range of motion \[ROM\], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.
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?: