NCT06738693

External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes

External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: B.P. Koirala Institute of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radius Fractures

Interventions

Type	Name	Description
PROCEDURE	External Fixation	External fixation involves the stabilization of unstable intra-articular distal radius fractures using an external fixator. The procedure is performed under anesthesia, with fixator pins placed percutaneously into the proximal and distal fragments of the radius. Postoperative care includes regular cleaning of pin tracts, early mobilization exercises for adjacent joints, and fixator removal upon radiological confirmation of fracture healing, typically between 6 to 8 weeks post-surgery.
PROCEDURE	Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate	ORIF using a volar locking plate is performed to anatomically reduce and stabilize unstable intra-articular distal radius fractures. The procedure is conducted under anesthesia, involving an open approach through the volar aspect of the wrist. The volar locking plate is secured with screws to provide rigid fixation, enabling early mobilization. Postoperative follow-up includes evaluation of functional outcomes, union rates, and potential complications.

Timeline

• Start date: 2019-12-23
• Primary completion: 2020-09-12
• Completion: 2020-11-14
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: Nepal