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

Metacarpal Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02718170
• Other study ID #: 00048356
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2026

Study information

• Verified date: April 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Metacarpal Fracture

Intervention

Procedure:
• Buried Intramedullary K-wire Fixation

• Plate and Screw Fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability as measured by Disability of Arm, Shoulder and Hand Score		3 months
Secondary	Total Active Motion in degrees	Measured by goniometer	3 months
Secondary	Grip Strength		3 months
Secondary	Disability as measured by Disability of Arm, Shoulder and Hand Score		1 year