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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03402269
Enrollment
30
Registered
2018-01-18
Start date
2018-01-10
Completion date
2022-12-31
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Clavicle Fracture

Brief summary

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.

Interventions

OTHERClavicle 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

Sponsors

Prisma Health-Upstate
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Range of motionat 1 year post injuryRange of motion measured by goniometer
Radiographic healingat 1 year post injuryRadiographic evidence of healing on 3 of 4 cortices

Secondary

MeasureTime frameDescription
QuickDashat 3 months, 6 months and 12 monthsQuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand
PODCIat 3 months, 6 months and 12 monthsAdolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population

Other

MeasureTime frameDescription
Strength Measurements6 months and 12 monthsUpper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026