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

NCT07186829 | Not Yet Recruiting

• 1 other identifier: RECHMPL24_0382
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hand; fracture; ostheosynthesis; screw; plate; k-wire; phalanx; metacarpal

Outcome Measures

Primary Outcomes (1)

• Pulp-to-palm distance at 6 weeks

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

  at 6 weeks

Secondary Outcomes (7)

• Range of motion

  at 3 weeks, 6 weeks, 3months, 6 months and 12 months

• Bone Healing

  3weeks, 6 weeks, 3months, 6months, 12months

• Cost analysis of each technique at 12months

  12months

• Complications

  3weeks, 6 weeks, 3months, 6months, 12months

• Grip strength

  3months, 6months, 12months

Study Arms (3)

Percutanous pinning

ACTIVE COMPARATOR

closed reduction, two percutaneous pins

Device: Percutanous pinning

Locked plate

ACTIVE COMPARATOR

open reduction, dorsal approach, 3 screws proximal and distal

Device: Locked plate

Intramedullary screw

ACTIVE COMPARATOR

1 cm dorsal incision, closed reduction, internal compression screw

Device: Intramedullary screw

Interventions

Percutanous pinning DEVICE

Similar to arm - closed reduction, two percutaneous pins

Also known as: K-wire, Kirchner wire

Percutanous pinning

Locked plate DEVICE

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

Also known as: Locking plate

Locked plate

Intramedullary screw DEVICE

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

Also known as: Intramedullary compression screw, Herbert screw

Intramedullary screw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, Occitanie, 34090, France

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Bone Wires

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Pierre-Emmanuel Chammas, MD, MSc

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Emmanuel Chammas, MD, MSc

CONTACT

+33467338537; pe-chammas@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)