Radius Fractures
Conditions
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.
Interventions
PROCEDUREExternal 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.
PROCEDUREOpen 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.
Sponsors
B.P. Koirala Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Nepal
Outcome results
None listed