Clinical trial NCT02718170: Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures
Official title: Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Metacarpal Fracture
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 110
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disability as measured by Disability of Arm, Shoulder and Hand Score
timeFrame: 3 months
Secondary outcomes:
measure: Total Active Motion in degrees
timeFrame: 3 months
measure: Grip Strength
timeFrame: 3 months
measure: Disability as measured by Disability of Arm, Shoulder and Hand Score
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Prisma Health-Upstate
name: John Millon, MD
role: PRINCIPAL_INVESTIGATOR
References: