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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Similar to arm - closed reduction, two percutaneous pins
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
University Hospital of Montpellier
Montpellier, Occitanie, France
Pulp-to-palm distance at 6 weeks
Global range of motion measured by pulp-to-palm distance at 6 weeks
Time frame: at 6 weeks
Range of motion
Flexion and extension angle in degrees for MCP and PIP joints
Time frame: at 3 weeks, 6 weeks, 3months, 6 months and 12 months
Bone Healing
Radiographical bone healing with routine AP and lateral x-rays
Time frame: 3weeks, 6 weeks, 3months, 6months, 12months
Cost analysis of each technique at 12months
Relative cost between each technique for intra and post operative care
Time frame: 12months
Complications
Every clinical and paraclinical complication that may occur
Time frame: 3weeks, 6 weeks, 3months, 6months, 12months
Grip strength
Grip strength measured in kg with a validated JAMAR® Hand Dynamometer
Time frame: 3months, 6months, 12months
QuickDASH PROM score
Functionnal recovery evaluated with the QuickDASH PROM score
Time frame: 3months, 6months, 12months
Patient satisfaction
Patient satisfaction evaluated with visual analogue scale (VAS)
Time frame: 3months, 6months, 12months
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