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

NCT ID: NCT07186829

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hand Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutanous pinning

closed reduction, two percutaneous pins

Group Type ACTIVE_COMPARATOR

Percutanous pinning

Intervention Type DEVICE

Similar to arm - closed reduction, two percutaneous pins

Locked plate

open reduction, dorsal approach, 3 screws proximal and distal

Group Type ACTIVE_COMPARATOR

Locked plate

Intervention Type DEVICE

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

Intramedullary screw

1 cm dorsal incision, closed reduction, internal compression screw

Group Type ACTIVE_COMPARATOR

Intramedullary screw

Intervention Type DEVICE

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

Interventions

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Percutanous pinning

Similar to arm - closed reduction, two percutaneous pins

Intervention Type DEVICE

Locked plate

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

Intervention Type DEVICE

Intramedullary screw

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

Intervention Type DEVICE

Other Intervention Names

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K-wire Kirchner wire Locking plate Intramedullary compression screw Herbert screw

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Emmanuel Chammas, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University Hospital of Montpellier

Montpellier, Occitanie, France

Site Status

Countries

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France

Central Contacts

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Pierre-Emmanuel Chammas, MD, MSc

Role: CONTACT

+33467338537

Facility Contacts

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Pierre-Emmanuel Chammas, MD, MSc

Role: primary

+330467338537

Other Identifiers

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RECHMPL24_0382

Identifier Type: -

Identifier Source: org_study_id

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