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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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02718170
Enrollment
25
Registered
2016-03-24
Start date
2015-03-01
Completion date
2025-08-26
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metacarpal Fracture

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.

Interventions

PROCEDUREBuried Intramedullary K-wire Fixation
PROCEDUREPlate and Screw Fixation

Sponsors

Prisma Health-Upstate
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Disability as measured by Disability of Arm, Shoulder and Hand Score3 months

Secondary

MeasureTime frameDescription
Total Active Motion in degrees3 monthsMeasured by goniometer
Grip Strength3 months
Disability as measured by Disability of Arm, Shoulder and Hand Score1 year

Contacts

PRINCIPAL_INVESTIGATORJohn Millon, MD

Prisma Health-Upstate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026