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NCT Number: NCT07186829

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Montpellier

Montpellier, Occitanie, 34090, France

Location contact

Pierre-Emmanuel Chammas, MD, MSc

CONTACT

[email protected]

+330467338537

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutanous pinning

Device

Similar to arm - closed reduction, two percutaneous pins

Other names: K-wire, Kirchner wire

Locked plate

Device

Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal

Other names: Locking plate

Intramedullary screw

Device

Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw

Other names: Intramedullary compression screw, Herbert screw

Primary outcomes

  1. Pulp-to-palm distance at 6 weeks

    Time frame: at 6 weeks

    Global range of motion measured by pulp-to-palm distance at 6 weeks

Secondary outcomes

  1. Range of motion

    Time frame: at 3 weeks, 6 weeks, 3months, 6 months and 12 months

    Flexion and extension angle in degrees for MCP and PIP joints

  2. Bone Healing

    Time frame: 3weeks, 6 weeks, 3months, 6months, 12months

    Radiographical bone healing with routine AP and lateral x-rays

  3. Cost analysis of each technique at 12months

    Time frame: 12months

    Relative cost between each technique for intra and post operative care

  4. Complications

    Time frame: 3weeks, 6 weeks, 3months, 6months, 12months

    Every clinical and paraclinical complication that may occur

  5. Grip strength

    Time frame: 3months, 6months, 12months

    Grip strength measured in kg with a validated JAMAR® Hand Dynamometer

  6. QuickDASH PROM score

    Time frame: 3months, 6months, 12months

    Functionnal recovery evaluated with the QuickDASH PROM score

  7. Patient satisfaction

    Time frame: 3months, 6months, 12months

    Patient satisfaction evaluated with visual analogue scale (VAS)

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre-Emmanuel Chammas, MD, MSc

CONTACT

[email protected]

+33467338537

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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.

Acronym: FinXger

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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