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

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Hand Fractures

Treatments: Device: Locked plate; Device: Intramedullary screw; Device: Percutanous pinning

Study type: Interventional

Funder types: Other

Identifiers

NCT07186829

RECHMPL24_0382

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Simple transverse extra-articular fractures of proximal or diaphyseal phalanges/metacarpals with surgical indication

Exclusion criteria

• Thumb fracture, open fracture, ischemia, pathological fracture, previous fracture, denial of consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

111 participants in 3 patient groups

Percutanous pinning

Active Comparator group

Description:

closed reduction, two percutaneous pins

Treatment:

Device: Percutanous pinning

Locked plate

Active Comparator group

Description:

open reduction, dorsal approach, 3 screws proximal and distal

Treatment:

Device: Locked plate

Intramedullary screw

Active Comparator group

Description:

1 cm dorsal incision, closed reduction, internal compression screw

Treatment:

Device: Intramedullary screw