Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

Completed

• Conditions: Metacarpal Fracture
• Interventions: Device: Implant

• Registration Number: NCT06631924
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-04-23
• Primary Completion: 2024-04-16
• Study Completion: 2024-04-16
• Study First Submitted: 2024-09-24
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
• Operative Cohort: Patients who undergo hand surgery at University of Colorado Hospital and Denver	Implant	• Operative Cohort: 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

Primary Outcome Measures

Name	Time	Method
Post-operative primary Outcomes	30 Days	Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure score.

Secondary Outcome Measures

Name	Time	Method
Pain scale	30-days	Pain quantified on Graphic Rating Scale (GRS)
Measurement of range	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.
Operative complications	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.

Trial Locations

Locations (1)

University of Colorado, Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States