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NOT YET RECRUITING
NCT07186829
NA

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2025-11-30

Completion Date

2027-11-30

Last Updated

2025-09-22

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

University Hospital of Montpellier

Montpellier, Occitanie, France