Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449755
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Elastic Nail Versus Screw for Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Elastic Nail Versus Screw for Closed Reduction and Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck a Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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 goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture The main questions it aims to answer are
Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application
Can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application Patients will be followed up at the 1st week 1st month and 3rd month postoperatively Functionality will be evaluated with Quick DASH score at the 3rd month At the 1st and 3rd month controls grip strength will be evaluated At the same time metacarpal shortening and angulations will be measured on x-ray Researchers will compare percutaneous screw and elastic nail group to see grip strength healing time and radiologic parameter difference
Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application
Can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application Patients will be followed up at the 1st week 1st month and 3rd month postoperatively Functionality will be evaluated with Quick DASH score at the 3rd month At the 1st and 3rd month controls grip strength will be evaluated At the same time metacarpal shortening and angulations will be measured on x-ray Researchers will compare percutaneous screw and elastic nail group to see grip strength healing time and radiologic parameter difference
Detailed Description:
In this study patients admitted to the emergency department with displaced fifth metacarpal neck fracture will be included Exclusion criteria will include patients with other concomitant trauma open fractures fractures with intraarticular joint extension and previous hand surgery in which the hand anatomy was distorted Patients between the ages of 18 and 60 who have more than 30 degrees of angulation from the 30 degree hand pronation radiograph at admission and who consent to surgery will be included in the study One of the two groups in the study will undergo closed reduction followed by percutaneous intramedullary retrograde screw fixation while the other group will undergo intramedullary antegrade elastic nail application Patients will be followed up with ulnar gutter splint for the first week postoperatively After the first week the splint will be removed and range of motion gripping and pinching exercises will be given to the patients
Radiological examinations dorsal angulation and metacarpal shortening will be measured will be performed in the first week first and third months postoperatively Hand grip strength will be measured with Cambry dynamometer at the first and third month At the 3rd month upper extremity functionality will be evaluated with Quick DASH score and a comparison will be made between the two groups
Randomisation will be performed with an internet-based application Clinical ethics committee approval was obtained before the study started
Radiological examinations dorsal angulation and metacarpal shortening will be measured will be performed in the first week first and third months postoperatively Hand grip strength will be measured with Cambry dynamometer at the first and third month At the 3rd month upper extremity functionality will be evaluated with Quick DASH score and a comparison will be made between the two groups
Randomisation will be performed with an internet-based application Clinical ethics committee approval was obtained before the study started
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