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Clinical Trials/NCT06631924
NCT06631924CompletedNot Applicable

Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

University of Colorado, Denver1 site in 1 country40 target enrollmentStarted: April 23, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Post-operative primary Outcomes

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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