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

B.P. Koirala Institute of Health Sciences

Status: Completed

Conditions: Radius Fractures

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06738693

IRC/1656/019

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

External Fixation

Experimental group

Description:

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.

Treatment:

Procedure: External Fixation

Volar Locking Plate

Experimental group

Description:

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.

Treatment:

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