NCT05425758

Brief Summary

This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 11, 2022

Last Update Submit

June 15, 2022

Conditions

Pediatric Distal Forearm Fractures

Keywords

Optimal index for Pediatric distal forearm fractures

Outcome Measures

Primary Outcomes (5)

  • The cast index

    formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.

    4 weeks observation after reduction and applying cast.

  • The gap index

    formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.

    4 weeks observation after reduction and applying cast.

  • The padding index

    formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.

    4 weeks observation after reduction and applying cast.

  • The Canterbury index

    formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.

    4 weeks observation after reduction and applying cast.

  • The three-point index

    4 weeks observation after reduction and applying cast.

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children 3-12 years of age with displaced distal forearm fractures requiring manipulation for and will be treated with casting.

You may qualify if:

  • Males or females 3 to 12 years old.
  • Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.

You may not qualify if:

  • Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires.
  • Children whose casts is split will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of orthopedic surgery

Study Record Dates

First Submitted

June 11, 2022

First Posted

June 21, 2022

Study Start

July 1, 2022

Primary Completion

September 30, 2022

Study Completion

November 30, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06