Health TrialsbyHealthPanel

Volar Locking Plate Comparison With External Fixator

ConditionArticular Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMuhammad Aamir Latif

About this trial

Local data has shown conflicting results regarding the outcomes of volar locking plates versus external fixators in distal intra-articular radius fractures. Therefore, the current study was planned with the objective of comparing the outcome of a volar locking plate versus an external fixator in distal intra-articular radius fractures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any gender

Aged 20 to 60

with intra-articular fractures of the distal radius

The fracture lasted less than seven days

Disqualifiers

Patients with bilateral distal radius fractures and any further related injuries or fractures

Distal radius open fractures

Individuals receiving immunosuppressive, chemotherapeutic, or corticosteroid medications (based on medical history and records)

Individuals with underlying medical co-morbidities, such as diabetes and uncontrolled hypertension, (determined by their medical history and record)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Volar locking plates

    Procedure/Surgery

    Patients will be treated with volar locking plates. The distal radius fragments will be stabilized using the conventional modified Henry's volar technique with 2.4 mm locking compression plates.

  • External Fixator

    Procedure/Surgery

    Patients will be employed with an external fixator, directly fixing to the second or third metacarpal bone using 3-mm pins and the radius using 4-mm Schanz pins.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group-AExperimental treatment 1 intervention
Group B: Group-BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Operative time

Operative time will be measured in minutes from skin incision to skin closure.

Time frame
2 hours
2

Blood Loss

Blood loss will be estimated in milliliters, measuring clots in a suction bottle, the difference between the pre- and postoperative sponge weights using the 1 g-1 ml formula, and blood clots in a clenched fist.

Time frame
3 hours
3

Wrist function

Wrist function will be evaluated using the Mayo Wrist Score. Patient frequencies will be recorded, with scores of 90-100 points reflecting an excellent outcome, 80-89 points indicating a good outcome, 60-79 points representing a satisfactory outcome, and scores below 60 points denoting a poor outcome.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammad Aamir Latif

Lead sponsor

RESnTEC, Institute of Research

Sponsor institution

Source ClinicalTrials.gov
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