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

Adolescent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402269
• Other study ID #: Pro00066019
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Clavicle Fracture
• Fractures, Bone

Intervention

Other:
• Clavicle 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

Locations

Country	Name	City	State
United States	Greenville Hospital System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Strength Measurements	Upper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation	6 months and 12 months
Primary	Range of motion	Range of motion measured by goniometer	at 1 year post injury
Primary	Radiographic healing	Radiographic evidence of healing on 3 of 4 cortices	at 1 year post injury
Secondary	QuickDash	QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand	at 3 months, 6 months and 12 months
Secondary	PODCI	Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population	at 3 months, 6 months and 12 months