Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:46 PM
Study NCT ID:
NCT06738693
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes
Sponsor:
B.P. Koirala Institute of Health Sciences
Organization:
Study Overview
Official Title:
External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes
Status:
COMPLETED
Status Verified Date:
2024-12
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:
The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:
Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.
Participants will:
Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.
Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.
Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.
Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.
Participants will:
Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.
Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.
Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: