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Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06631924
Enrollment
40
Registered
2024-10-08
Start date
2020-04-23
Completion date
2024-04-16
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metacarpal Fracture

Keywords

fractures metacrapal

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

Interventions

DEVICEImplant

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative primary Outcomes30 DaysQuick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure score.

Secondary

MeasureTime frameDescription
Pain scale30-daysPain quantified on Graphic Rating Scale (GRS)
Measurement of range30-daysGoniometer 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 complications30-daysOperative complications including but not limited to: bone nonunion and malunion, superficial and deep infections, hardware failure, stiffness, revision surgery and tendon adhesions/rupture.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026