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

NCT07186829 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2025-09-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Pierre-Emmanuel Chammas, MD, MSc · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186829 on ClinicalTrials.gov