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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02718170
Other study ID # 00048356
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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