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

Completed

• Conditions: Adolescent; Clavicle Fracture
• Interventions: Other: Clavicle fracture injury- observation

• Registration Number: NCT03402269
• Lead Sponsor: Prisma Health-Upstate

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Primary Completion: 2020-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents with displaced clavicle fractures	Clavicle fracture injury- observation	Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study.

Primary Outcome Measures

Name	Time	Method
Range of motion	at 1 year post injury	Range of motion measured by goniometer
Radiographic healing	at 1 year post injury	Radiographic evidence of healing on 3 of 4 cortices

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States