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Completed

NCT Number: NCT03402269

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

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.

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Key information

Conditions

Clavicle Fracture Adolescent

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clavicle fracture injury- observation

Other

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

Primary outcomes

  1. Range of motion

    Time frame: at 1 year post injury

    Range of motion measured by goniometer

  2. Radiographic healing

    Time frame: at 1 year post injury

    Radiographic evidence of healing on 3 of 4 cortices

Secondary outcomes

  1. QuickDash

    Time frame: at 3 months, 6 months and 12 months

    QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand

  2. 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

Other outcomes

  1. Strength Measurements

    Time frame: 6 months and 12 months

    Upper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jan 18, 2018
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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