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

NCT03402269 | Completed

• 1 other identifier: Pro00066019
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture; Adolescent

Outcome Measures

Primary Outcomes (2)

• Range of motion

  Range of motion measured by goniometer

  at 1 year post injury

• Radiographic healing

  Radiographic evidence of healing on 3 of 4 cortices

  at 1 year post injury

Secondary Outcomes (2)

• QuickDash

  at 3 months, 6 months and 12 months

• PODCI

  at 3 months, 6 months and 12 months

Other Outcomes (1)

• Strength Measurements

  6 months and 12 months

Study Arms (1)

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

Interventions

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

Adolescents with displaced clavicle fractures

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Study Officials

• Christopher C Bray, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: January 10, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)