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

Not Applicable

Recruiting

• Conditions: Clavicle Fracture
• Interventions: Device: Clavicular brace

• Registration Number: NCT06276218
• Lead Sponsor: Prince of Songkla University

Brief 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.

Detailed 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,

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2024-02
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-16
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
standard clavicular brace	Clavicular brace	-
self-adjustable clavicular brace	Clavicular brace	-

Primary Outcome Measures

Name	Time	Method
DASH	1, 2, 4, 6, 12 week	DISABILITIES OF THE ARM, SHOULDER AND HAND

Secondary Outcome Measures

Name	Time	Method
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction	1, 2, 4, 6, 12 week	Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Songkla, Hatyai, Thailand