Skip to main content
OpenTrials
Completed

NCT Number: NCT06631924

Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metacarpal Fracture

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation

  • Non-operative Cohort: Patients who underwent non-operative management of closed extra-articular metacarpal fractures at both the University of Colorado and Denver Health Medical Center will also be reviewed.

Exclusion criteria

Open metacarpal fractures (defined as any fracture associated with a laceration or break in skin continuity near the fracture site)

  • Patients with previous history of metacarpal nonunion or malunion corrections on the affected digit
  • Metacarpal fractures with intraarticular extension

Treatment and study plan

implant

Device

Intramedullary headless hardware systems were utilized to place hardware in85 a retrograde manner from the metacarpophalangeal joint.

Primary outcomes

  1. Post-operative primary Outcomes

    Time frame: 30 Days

    Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure score.

Secondary outcomes

  1. Pain scale

    Time frame: 30-days

    Pain quantified on Graphic Rating Scale (GRS)

  2. Measurement of range

    Time frame: 30-days

    Goniometer measurements of range of motion at metacarpophalangeal joint (MP), proximal interphalangeal joint (PIP), distal interphalangeal joint (DIP), in addition to any extensor lag at the MP joint.

  3. Operative complications

    Time frame: 30-days

    Operative complications including but not limited to: bone nonunion and malunion, superficial and deep infections, hardware failure, stiffness, revision surgery and tendon adhesions/rupture.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.