NCT03396965

Brief Summary

Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated distal radius fractures in adult patients in the emergency department setting.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 5, 2018

Last Update Submit

January 11, 2018

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • Reduction quality

    Fracture alignment measured on post-reduction radiographs

    Immediately post reduction

Study Arms (2)

Mini-c-arm

EXPERIMENTAL

Fluoroscopically aided reductions

Other: Mini-c-arm

Standard

NO INTERVENTION

Interventions

Mini-c-armOTHER

Fluoroscopy used to aid reduction of distal radius fracture

Mini-c-arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Closed distal radius fracture requiring reduction

You may not qualify if:

  • Open, other ipsilateral upper extremity fractures, pregnant, incarcerated, less than 18 yo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients randomized to fluoroscopically-aided reduction of fracture, versus no fluoroscopic guidance
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 11, 2018

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share