NCT07186829

Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers

Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers: Centromedullary Screw Osteosynthesis Versus Pinning Versus Locked Plate.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hand Fractures

Interventions

Type	Name	Description
DEVICE	Percutanous pinning	Similar to arm - closed reduction, two percutaneous pins
DEVICE	Locked plate	Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
DEVICE	Intramedullary screw	Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw

Timeline

• Start date: 2025-11-30
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: France