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

NCT ID: NCT02718170

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2027-08-31

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.

Conditions

Metacarpal Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Buried Intramedullary K-wire Fixation

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Plate and Screw Fixation

Intervention Type: PROCEDURE

Interventions

Buried Intramedullary K-wire Fixation

Intervention Type: PROCEDURE

Plate and Screw Fixation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Millon, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Other Identifiers

00048356

Identifier Type: -

Identifier Source: org_study_id