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

Clavicle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276218
• Other study ID #: PSU
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 16, 2024

Study information

• Verified date: February 2024
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 16, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Device:
• Clavicular brace
Clavicular brace for conservative treatment of closed midshaft clavicular fractures

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Songkla	Hatyai

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH	DISABILITIES OF THE ARM, SHOULDER AND HAND	1, 2, 4, 6, 12 week
Secondary	Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction	Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction	1, 2, 4, 6, 12 week