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Clinical Trials/NCT06631924
NCT06631924
Completed
Not Applicable

Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

University of Colorado, Denver1 site in 1 country40 target enrollmentApril 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metacarpal Fracture
Sponsor
University of Colorado, Denver
Enrollment
40
Locations
1
Primary Endpoint
Post-operative primary Outcomes
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
April 23, 2020
End Date
April 16, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post-operative primary Outcomes

Time Frame: 30 Days

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

Secondary Outcomes

  • Pain scale(30-days)
  • Measurement of range(30-days)
  • Operative complications(30-days)

Study Sites (1)

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