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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BPKIHS

Dharān, Koshi, 56700, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 18, 2024
Registry last updated: Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed