Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures

Not Applicable

• Conditions: Metacarpal Fracture
• Interventions: Procedure: Buried Intramedullary K-wire Fixation; Procedure: Plate and Screw Fixation

• Registration Number: NCT02718170
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.

Detailed Description

Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.

The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• The patient has an unstable extra-articular metacarpal fracture that meets operative indications
• Informed consent is obtained from the patient or proxy
• Male or female who are 16 years of age or older

Exclusion Criteria

• If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)
• Pathological Fracture
• Greater than 21 days from fracture to definitive open reduction and internal fixation
• If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation
• Highly comminuted diaphyseal fractures
• Articular fractures
• Multiple fractures involving bones other than another metacarpal in the same upper extremity
• The patient had a previous upper extremity injury that has limited hand function or finger range of motion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buried Intramedullary K-wire Fixation	Buried Intramedullary K-wire Fixation	Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire.
Plate and Screw Fixation	Plate and Screw Fixation	Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion.

Primary Outcome Measures

Name	Time	Method
Disability as measured by Disability of Arm, Shoulder and Hand Score	3 months

Secondary Outcome Measures

Name	Time	Method
Total Active Motion in degrees	3 months	Measured by goniometer
Disability as measured by Disability of Arm, Shoulder and Hand Score	1 year
Grip Strength	3 months