The goal of this randomized controlled trial is to compare the effectiveness, complications, and cost-effectiveness of three surgical techniques (intramedullary screw fixation, locked plating, and percutaneous pinning) for treating simple transverse extra-articular fractures of the proximal phalanges and metacarpals (excluding the thumb) in adult patients. The main questions it aims to answer are:
The primary outcome is to define which technique results in better functional outcomes, as measured by pulp-to-palm distance at 6 weeks?
The main secondary outcome is to define which technique has lower complication rates and is more cost-effective over 12 months?
Participants will be randomly assigned to one of the three surgical techniques (intramedullary screw fixation, locked plating, or percutaneous pinning). Follow-up visits at weeks: 3, 6 and months: 3,6 and final follow-up at 12 months will assess hand function, range of motion, grip strength, radiographic healing, complications, satisfaction, and costs.
Simple transverse extra-articular fractures of proximal or diaphyseal phalanges/metacarpals with surgical indication
Thumb fracture, open fracture, ischemia, pathological fracture, previous fracture, denial of consent
Parallel
Percutanous pinning
DeviceSimilar to arm - closed reduction, two percutaneous pins
Locked plate
DeviceSimilar to arm - open reduction, dorsal approach, 3 screws proximal and distal
Intramedullary screw
DeviceSimilar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
Pulp-to-palm distance at 6 weeks
Global range of motion measured by pulp-to-palm distance at 6 weeks
Range of motion
Flexion and extension angle in degrees for MCP and PIP joints
Bone Healing
Radiographical bone healing with routine AP and lateral x-rays
Cost analysis of each technique at 12months
Relative cost between each technique for intra and post operative care
Complications
Every clinical and paraclinical complication that may occur
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This trial is not recruiting at the moment. You can still explore other options:
