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

NCT06738693 | Completed DMC

• 1 other identifier: IRC/1656/019
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fractures

Outcome Measures

Primary Outcomes (1)

• Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney

  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.

  24 weeks post-surgery

Study Arms (2)

External Fixation

EXPERIMENTAL

Patients in this arm will undergo external fixation for unstable intra-articular distal radius fractures. The procedure involves the placement of an external fixator to stabilize the fracture, followed by postoperative care including pin tract cleaning and removal of the fixator after radiological confirmation of bone healing (6-8 weeks). Functional outcomes, fracture union, and complications will be assessed at regular intervals.

Procedure: External Fixation

Volar Locking Plate

EXPERIMENTAL

Patients in this arm will undergo open reduction and internal fixation (ORIF) using a volar locking plate for unstable intra-articular distal radius fractures. This method provides stable fixation, allowing early mobilization. Postoperative outcomes, including functional scores, union rates, and complications, will be evaluated at follow-up visits.

Procedure: Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate

Interventions

External Fixation PROCEDURE

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.

External Fixation

Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate PROCEDURE

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.

Volar Locking Plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

BPKIHS

Dharān, Koshi, 56700, Nepal

Location

MeSH Terms

Conditions

Radius Fractures

Interventions

External Fixators; Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 18, 2024
• Study Start: December 23, 2019
• Primary Completion: September 12, 2020
• Study Completion: November 14, 2020
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

NE (1)