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

NCT02718170 | Terminated

• 1 other identifier: 00048356
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metacarpal Fracture

Outcome Measures

Primary Outcomes (1)

• Disability as measured by Disability of Arm, Shoulder and Hand Score

  3 months

Secondary Outcomes (3)

• Total Active Motion in degrees

  3 months

• Grip Strength

  3 months

• Disability as measured by Disability of Arm, Shoulder and Hand Score

  1 year

Study Arms (2)

Buried Intramedullary K-wire Fixation

EXPERIMENTAL

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

Plate and Screw Fixation

ACTIVE COMPARATOR

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

Interventions

Plate and Screw Fixation PROCEDURE

Plate and Screw Fixation

Buried Intramedullary K-wire Fixation PROCEDURE

Buried Intramedullary K-wire Fixation

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• John Millon, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2015
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share