Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-26
Brief Title:
Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
Status:
NOT_YET_RECRUITING
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:
BoxerFx
Brief Summary:
The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture
Detailed Description:
This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent Informed written consent will be obtained Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software Randomizer by the Medical University of Graz Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment Both groups will receive the allocated bandage or splint for 4 weeks The clinical outcome will be assessed 12 weeks after trauma
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent Informed written consent will be obtained Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software Randomizer by the Medical University of Graz Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment Both groups will receive the allocated bandage or splint for 4 weeks The clinical outcome will be assessed 12 weeks after trauma
Study Oversight
Has Oversight DMC:
None
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?:
None