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

Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study

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

Study Overview

• Status: Terminated
• Conditions: Metacarpal Fracture
• Intervention / Treatment: Procedure: Buried Intramedullary K-wire Fixation; Procedure: Plate and Screw Fixation

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Buried Intramedullary K-wire Fixation
Active Comparator: 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.	Procedure: Plate and Screw Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disability as measured by Disability of Arm, Shoulder and Hand Score	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: John Millon, MD, Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): August 26, 2025
• Study Completion (Actual): August 26, 2025

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimated): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Prostheses and Implants; Internal Fixators; Bone Plates
• Other Study ID Numbers: 00048356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO