Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

NCT06631924 | Completed FDA Device

• 1 other identifier: 20-0802
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metacarpal Fracture

Keywords

fractures metacrapal

Outcome Measures

Primary Outcomes (1)

• Post-operative primary Outcomes

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

  30 Days

Secondary Outcomes (3)

• Pain scale

  30-days

• Measurement of range

  30-days

• Operative complications

  30-days

Study Arms (1)

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

• 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

Device: Implant

Interventions

Implant DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Matt Iorio, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 8, 2024
• Study Start: April 23, 2020
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)