Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study

March 27, 2023 updated by: Prisma Health-Upstate
Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

11-17 years old with displaced fractures of the middle third of the clavicle

Description

Inclusion Criteria:

  • 11-17 years old with fractures of the middle third of the clavicle
  • Displaced 100% the width of the clavicle or shortened 1 centimeter
  • Operative and non-operative treated clavicles will be eligible for enrollment

Exclusion Criteria:

  • Open clavicle fractures
  • Ipsilateral shoulder injuries
  • Fractures involving the lateral ligaments or the sternoclavicular joint
  • Bilateral clavicle fractures
  • Pathologic fractures
  • Refractures
  • Fractures with neurovascular compromise
  • Displaced fractures with impending skin compromise
  • If there has been more than 21 days between injury and enrollment
  • Patients with cognitive disabilities that inhibit the completion of the questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adolescents with displaced clavicle fractures
Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study.
Other: Clavicle fracture injury- observation
The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: at 1 year post injury
Range of motion measured by goniometer
at 1 year post injury
Radiographic healing
Time Frame: at 1 year post injury
Radiographic evidence of healing on 3 of 4 cortices
at 1 year post injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QuickDash
Time Frame: at 3 months, 6 months and 12 months
QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand
at 3 months, 6 months and 12 months
PODCI
Time Frame: at 3 months, 6 months and 12 months
Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population
at 3 months, 6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength Measurements
Time Frame: 6 months and 12 months
Upper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00066019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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