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

Not Applicable

Not yet recruiting

• Conditions: Hand Fractures

• Registration Number: NCT07186829
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-11-30
• Primary Completion: 2026-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulp-to-palm distance at 6 weeks	at 6 weeks	Global range of motion measured by pulp-to-palm distance at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Range of motion	at 3 weeks, 6 weeks, 3months, 6 months and 12 months	Flexion and extension angle in degrees for MCP and PIP joints
Bone Healing	3weeks, 6 weeks, 3months, 6months, 12months	Radiographical bone healing with routine AP and lateral x-rays
Cost analysis of each technique at 12months	12months	Relative cost between each technique for intra and post operative care
Complications	3weeks, 6 weeks, 3months, 6months, 12months	Every clinical and paraclinical complication that may occur
Grip strength	3months, 6months, 12months	Grip strength measured in kg with a validated JAMAR® Hand Dynamometer
QuickDASH PROM score	3months, 6months, 12months	Functionnal recovery evaluated with the QuickDASH PROM score
Patient satisfaction	3months, 6months, 12months	Patient satisfaction evaluated with visual analogue scale (VAS)

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, Occitanie, France