Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study

Prince of Songkla University

Status

Enrolling

Conditions

Clavicle Fracture

Treatments

Device: Clavicular brace

Study type

Interventional

Funder types

Other

Identifiers

NCT06276218

PSU

Details and patient eligibility

About

A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.

Full description

Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,

Enrollment

68 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient with aged between 18 - 75 years old
Closed isolated fracture midshaft of clavicle within 9 days after the injury date

Exclusion criteria

After bracing, fracture displacement and/or shortening > 2 cm or fracture comminution > 3 fragments
Segmental fracture
Open fracture
Impending open fracture (soft tissue compromise/skin lesion)
Ipsilateral upper extremities fracture which disturbs clavicular bracing
Floating shoulder which surgical treatment is indicated.
Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing
Pathologic fracture
Patient has limitation for clavicular brace application
Pregnant women