Clinical trial NCT06631924: Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes
Official title: Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metacarpal Fracture
Keywords: fractures metacrapal
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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

Primary outcomes:
measure: Post-operative primary Outcomes
timeFrame: 30 Days
Secondary outcomes:
measure: Pain scale
timeFrame: 30-days
measure: Measurement of range
timeFrame: 30-days
measure: Operative complications
timeFrame: 30-days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Matt Iorio, MD
role: PRINCIPAL_INVESTIGATOR
References: