External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes
NCT ID: NCT06738693
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2019-12-23
2020-11-14
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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External Fixation
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.
External 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.
Volar Locking Plate
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.
Open 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.
Interventions
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External 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.
Open 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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with recent (\<1 week) intra-articular distal end radius fractures.
* Willing and able to provide informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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B.P. Koirala Institute of Health Sciences
OTHER
Responsible Party
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Sabir Kumar Khadka
Junior Resident
Locations
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BPKIHS
Dharān, Koshi, Nepal
Countries
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Other Identifiers
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IRC/1656/019
Identifier Type: -
Identifier Source: org_study_id