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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metacarpal Fracture

Intervention / Treatment
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* Procedure: Buried Intramedullary K-wire Fixation
* Procedure: Plate and Screw Fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buried Intramedullary K-wire Fixation<br>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<br> <br> |
| Active Comparator: Plate and Screw Fixation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |