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

Not Applicable

Completed

• Conditions: Radius Fractures

• Registration Number: NCT06738693
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-23
• Primary Completion: 2020-09-12
• Study Completion: 2020-11-14
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients aged 18 years or older.
• Diagnosed with recent (<1 week) intra-articular distal end radius fractures.
• Willing and able to provide informed consent.

Exclusion Criteria

• Open fractures classified as Gustilo grade II or higher.
• Fracture avulsion or dislocation.
• Vascular injury associated with the fracture.
• Extra-articular fractures of the distal radius.
• Preexisting joint or carpal bone disease affecting rehabilitation.
• Patients unwilling to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney	24 weeks post-surgery	The primary outcome will be the functional outcome of the wrist assessed using the Green and O'Brien scoring system modified by Cooney. This scoring system evaluates four components: pain, function, range of motion, and grip strength, each weighted appropriately to provide a composite score. Scores will be compared between the external fixation and volar plating groups to determine the superiority of either intervention in restoring wrist function.

Trial Locations

Locations (1)

BPKIHS; 🇳🇵 Dharan, Koshi, Nepal