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

Prisma Health-Upstate30 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Clavicle Fracture Adolescent

Interventions

Clavicle fracture injury- observationOTHER

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

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Range of motion

Range of motion measured by goniometer

Time frame: at 1 year post injury

Radiographic healing

Radiographic evidence of healing on 3 of 4 cortices

Time frame: at 1 year post injury

Secondary Outcomes

QuickDash

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

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

PODCI

Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population